Identity
- Trade Name
- PDT, Inc. FDA UDI
- Generic Name
- Periodontal curette FDA UDI
- Device Name
- Kit Includes: R026 Amazing Gracey™ 11-12 R028 Amazing Gracey™ 13-14 R061 Barnhart 5-6 R093 N128-L5 Mini R096 N1 R130S Jack B. Nimble® Slim Scaler R135 204S R138 Montana Jack® R166 Explorer 5 R167 Explorer ODU 11-12 R215 Probe WRS ACE™-UNC12 R245 Mirror Handle (Cone-Socket) T009D-F15 FlipTop™ Cassette 'D' - Fixed Rack 15 T055 Double-Sided PrecisionReflect HD FDA UDI
- Model / Reference
- R985 Rev B Andy RDH Student Kits FDA UDI
- Description
- Kit Includes: R026 Amazing Gracey™ 11-12 R028 Amazing Gracey™ 13-14 R061 Barnhart 5-6 R093 N128-L5 Mini R096 N1 R130S Jack B. Nimble® Slim Scaler R135 204S R138 Montana Jack® R166 Explorer 5 R167 Explorer ODU 11-12 R215 Probe WRS ACE™-UNC12 R245 Mirror Handle (Cone-Socket) T009D-F15 FlipTop™ Cassette 'D' - Fixed Rack 15 T055 Double-Sided PrecisionReflect HD FDA UDI
Identifiers
- Catalog Number
- R983 Rev C FDA UDI
- Primary DI / UDI-DI
- 00813677025142 FDA UDI
- FDA Product Code
- EMS FDA UDIEMN FDA UDIEKB FDA UDIEIX FDA UDIEJB FDA UDIFSM FDA UDIEAX FDA UDI
- GMDN Term
- Periodontal curette 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 b8e2e8af-e8db-43ac-ba6a-4086c834158b 34 fields · synced Jun 9, 2026