DEVICE: PDT, Inc. (00813677024862)
Device Identifier (DI) Information
PDT, Inc.
R917 PDT Amazing Gracey™ Prophy Kit
In Commercial Distribution
R917
PDT, INC.
R917 PDT Amazing Gracey™ Prophy Kit
In Commercial Distribution
R917
PDT, INC.
Kit Includes:
T009C-F C-Series FlipTop™ Cassette - Fixed Rack 9
R026 Amazing Gracey™ 11-12
R028 Amazing Gracey™ 13-14
R061 Barnhart 5-6
R130 Jack B. Nimble®
R138 Montana Jack®
R144 Queen of Hearts™
R167 11-12 ODU Explorer
R195 Probe 12 (3-6-9-12)
R245 Cone Socket Mirror Handle
T050 #5 Mirror (15/16")
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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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.
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Active | false |
35320 | Manual dental scaler, reusable |
A hand-held dental instrument designed for removing calculus and other accretions from the surface and between the teeth during dental cleaning and periodontal (gum) therapy. It is typically designed as a one-piece instrument with a pointed, distal end of various shapes and sizes. Also known as a periodontic scaler, it can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. This is a reusable device.
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Active | false |
41660 | Periodontal curette |
A hand-held dental instrument with a sharp, hollow-ground blade, usually rounded and semicircular in cross-section, used with a pulling action to remove calculus of periodontal pockets and smooth root surfaces; it is not a gingival retraction cord packing tool. It is typically a double-ended instrument with a handle positioned centrally and is made of metal. This is a reusable device.
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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 |
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.
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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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EMN | Scaler, Periodontic |
EMS | Curette, Periodontic |
EIX | Probe, Periodontic |
FSM | Tray, Surgical, Instrument |
EAX | Mirror, Mouth |
EKB | Explorer, Operative |
EJB | Handle, Instrument, Dental |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
298b3441-9309-4395-a4a5-0f16f920405e
July 04, 2024
1
June 26, 2024
July 04, 2024
1
June 26, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined