Identity
- Trade Name
- PDT, Inc. FDA UDI
- Generic Name
- Dental restoration carver, amalgam, reusable FDA UDI
- Device Name
- Kit Includes: (T009D-F) D-Series FlipTop™ Cassette - Fixed Rack 9 (R138) Montana Jack® (R166) 5 Explorer (R195) 12 Probe (R245) Cone Socket Mirror Handle (R286) G2 Thin Composite (R362) 113 Off Angle Cord Packer (R375) Mixing Spatula-Applicator (R386) 38-39 Excavator (T042) Meriam Tweezers (T046) Miller Articulating Paper Forceps (T050) #5 Mirror (15/16") (T235) Aspirating Anesthetic Syringe Medium (T800) Iris Curved Scissors (11.5cm) FDA UDI
- Model / Reference
- R935 PDT Crown & Bridge Kit FDA UDI
- Description
- Kit Includes: (T009D-F) D-Series FlipTop™ Cassette - Fixed Rack 9 (R138) Montana Jack® (R166) 5 Explorer (R195) 12 Probe (R245) Cone Socket Mirror Handle (R286) G2 Thin Composite (R362) 113 Off Angle Cord Packer (R375) Mixing Spatula-Applicator (R386) 38-39 Excavator (T042) Meriam Tweezers (T046) Miller Articulating Paper Forceps (T050) #5 Mirror (15/16") (T235) Aspirating Anesthetic Syringe Medium (T800) Iris Curved Scissors (11.5cm) FDA UDI
Identifiers
- Catalog Number
- R935 FDA UDI
- Primary DI / UDI-DI
- 00813677024961 FDA UDI
- FDA Product Code
- DZN FDA UDIEAX FDA UDIFSM FDA UDIEMN FDA UDIEKB FDA UDIEIX FDA UDIEJB FDA UDIEKH FDA UDIEKC FDA UDIEGN FDA UDIEJY FDA UDIEIC FDA UDI
- GMDN Term
- Dental restoration carver, amalgam, 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, reusableManual 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 7490b7df-c9b0-4bf9-91df-ad90effe3c11 34 fields · synced Jun 9, 2026