DEVICE: PDT, Inc. (00813677024985)

Device Identifier (DI) Information

PDT, Inc.
R943 PDT Endo Kit
In Commercial Distribution
R943
PDT, INC.
00813677024985
GS1

1
125850144 *Terms of Use
Kit Includes: (T015E-F) E-Series FlipTop™ Cassette - Fixed Rack 15 with Standard Divider (R245) Cone Socket Mirror Handle (R311) DG 16 Explorer (R312) D11 Endo Spreader (R314) 1-3 Endo Plugger (R315) 5-7 Endo Plugger (R316) 9-11 Endo Plugger (R317) Glick 1 (R318) 31L Endo Excavator (T046) Miller Articulating Paper Forceps (T047) Endo Locking Pliers (T050) #5 Mirror (15/16") (T235) Aspirating Anesthetic Syringe Medium (T784) Ainsworth Rubber Dam Punch Forceps (T785) Ivory Rubber Dam Clamp Forceps (T786) Rubber Dam Frame (T863) Small Parts Basket
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
31776 Dental mirror, reusable
A hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. This is a reusable device.
Active false
64304 Manual non-rotary dental instrument handle
A hand-held, manual device designed to hold and facilitate manipulation of a non-powered, non-rotary dental instrument (e.g., endodontic file/rasp, implant extractor). It is designed to accept the patient-contact endpiece (not included) for ease of handling. This is a reusable device.
Active false
12143 Instrument tray, reusable
A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.
Active false
35812 Dental surgical probe, reusable
A slender, rod-like, hand-held manual dental surgical instrument intended to be used to explore, measure and/or perform therapeutic procedures during various types of dental surgical intervention. The distal end may be needle-like, hooked, or blunt; it is made of flexible or rigid metallic and/or synthetic polymer material and it may have scaled markings for measurements. This is a reusable device.
Active false
37678 Manual endodontic filling material spreader
A hand-held, manually-operated dental instrument specifically designed to compress filling materials in a root canal, mainly in a lateral direction. The working part is tapered, circular in cross-section and has a pointed tip. This is a reusable device.
Active false
41876 Endodontic plugger
A hand-held, manually-operated, dental instrument specifically designed to compress filling materials in a root canal, mainly in an axial direction. The working distal end is cylindrical or tapered, circular in cross-section, and has a flat-tipped end. This is a reusable device.
Active false
35811 Dental excavator, reusable
A hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. This is a reusable device.
Active false
35970 Dental irrigation/aspiration syringe
A hand-held manual dental device (a plunger-type syringe) designed to inject and/or aspirate a volume of solution into the working area in the oral cavity. It typically consists of a small syringe (e.g., 3 ml) and is used for washing and aspirating the pulp cavity and root canal to remove debris. It is hand-operated by the user who exerts a steady pressure on, e.g., thumb rings and/or swivel finger bars, which exerts pressure on the syringe plunger forcing the washing/rinsing fluids through an attached needle (e.g., a blunt or very fine needle) directly at the operative site. This is a reusable device.
Active false
35553 Rubber dam punch
A hand-held dental instrument used to place holes in rubber dam material to permit the passage of the dam over the crowns of the teeth. The handles are squeezed together and the plunger (punch) creates a hole in the rubber dam material. It is typically designed to create various hole sizes. This is a reusable device.
Active false
35851 Rubber dam clamp forceps
A hand-held dental instrument used for the insertion and removal of rubber dam clamps. It is typically designed with permanently joined handles pivoted scissor-like, and has small projections at the working end that fit into corresponding holes in the rubber dam clamp. It will typically have a sliding lock mechanism that locks the handles in position while the operator moves the rubber dam clamp around the tooth. This is a reusable device.
Active false
31849 Rubber dam frame
A flexible border that holds a rubber dam in a stretched state to improve access to the field of operation. It is typically made of a thick stainless steel U-shaped rod that has small hook-like retainers attached at intervals along its length. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EKB Explorer, Operative
EAX Mirror, Mouth
FSM Tray, Surgical, Instrument
EJB Handle, Instrument, Dental
EKK Spreader, Pulp Canal Filling Material, Endodontic
EKR Plugger, Root Canal, Endodontic
EKC Excavator, Dental, Operative
EIC Syringe, Periodontic, Endodontic, Irrigating
EJG Forceps, Rubber Dam Clamp
EJE Frame, Rubber Dam
MXP Bone Particle Collector
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Dry Heat Sterilization
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

3c1a803d-b8c1-4ab0-966a-b2cc27a641dc
July 05, 2024
1
June 27, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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