Identity
- Trade Name
- PDT, Inc. FDA UDI
- Generic Name
- Dental mirror, reusable FDA UDI
- Device Name
- 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") FDA UDI
- Model / Reference
- R970 Just Be Nice Hygiene Kit with Cassette FDA UDI
- Description
- 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") FDA UDI
Identifiers
- Catalog Number
- R970 FDA UDI
- Primary DI / UDI-DI
- 00813677024992 FDA UDI
- FDA Product Code
- EAX FDA UDIFSM FDA UDIEMS FDA UDIEMN FDA UDIEKB FDA UDIEIX FDA UDIEJB FDA UDI
- GMDN Term
- Dental mirror, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Instrument tray, reusablePeriodontal curetteManual dental scaler, reusableDental surgical probe, reusable
PDT, Inc. by PDT, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- PDT, Inc.
Sources (1)
- FDA UDI dc574fa0-3903-4190-afe7-717dad8b1c92 34 fields · synced Jun 9, 2026