Identity
- Trade Name
- PDT, Inc. FDA UDI
- Generic Name
- Manual dental scaler, reusable FDA UDI
- Device Name
- Kit Includes: T009C-D C-Series FlipTop™ Cassette - Double Rack 18 R043 Amazing Gracey™ 13-14 Extended Reach R044 Amazing Gracey™ 15-16 Extended Reach R061 Barnhart 5-6 R089 Mini Me™ R120 Montana 4-5™ R130 Jack B. Nimble® R138 Montana Jack® R144 Queen of Hearts™ R169 11-12 ODU Extended Reach Explorer R216 ACE™-12 Short Probe R245 Cone Socket Mirror Handle T042 Meriam Tweezers T050 #5 Mirror (15/16") FDA UDI
- Model / Reference
- R916 PDT SRP Kit FDA UDI
- Description
- Kit Includes: T009C-D C-Series FlipTop™ Cassette - Double Rack 18 R043 Amazing Gracey™ 13-14 Extended Reach R044 Amazing Gracey™ 15-16 Extended Reach R061 Barnhart 5-6 R089 Mini Me™ R120 Montana 4-5™ R130 Jack B. Nimble® R138 Montana Jack® R144 Queen of Hearts™ R169 11-12 ODU Extended Reach Explorer R216 ACE™-12 Short Probe R245 Cone Socket Mirror Handle T042 Meriam Tweezers T050 #5 Mirror (15/16") FDA UDI
Identifiers
- Catalog Number
- R916 FDA UDI
- Primary DI / UDI-DI
- 00813677024855 FDA UDI
- FDA Product Code
- EMN FDA UDIEMS FDA UDIEIX FDA UDIFSM FDA UDIEKB FDA UDIEAX FDA UDIEJY FDA UDIEJB FDA UDI
- GMDN Term
- Manual dental scaler, 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, reusableSurgical soft-tissue manipulation forceps, tweezers-like, reusablePeriodontal curetteManual dental scaler, 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 cba5e60b-b8fa-4c2a-9b6a-504423bafc36 34 fields · synced Jun 9, 2026