DEVICE: PDT, Inc. (00813677024992)
Device Identifier (DI) Information
PDT, Inc.
R970 Just Be Nice Hygiene Kit with Cassette
In Commercial Distribution
R970
PDT, INC.
R970 Just Be Nice Hygiene Kit with Cassette
In Commercial Distribution
R970
PDT, INC.
Kit Includes:
(T007B-F) B-Series FlipTop™ Cassette - Fixed Rack 7
(R006) 11-12 Amazing Gracey™ Extended Reach Mini
(R007) 13-14 Amazing Gracey™ Extended Reach Mini
(R064) Columbia 13-14
(R130S) Jack B. Nimble®
(R138) Montana Jack®
(R224) 23 Explorer-Williams O Probe
(R245) Cone Socket Mirror Handle
(T050) #5 Mirror (15/16")
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
No | |
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No | |
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.
|
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 |
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 |
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.
|
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.
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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 |
---|---|
EAX | Mirror, Mouth |
FSM | Tray, Surgical, Instrument |
EMS | Curette, Periodontic |
EMN | Scaler, Periodontic |
EKB | Explorer, Operative |
EIX | Probe, Periodontic |
EJB | Handle, Instrument, Dental |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
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
dc574fa0-3903-4190-afe7-717dad8b1c92
July 05, 2024
1
June 27, 2024
July 05, 2024
1
June 27, 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