Identity
- Trade Name
- PDT, Inc. FDA UDI
- Generic Name
- Dental mirror, reusable FDA UDI
- Device Name
- Kit Includes: T015E-F FlipTop™ Cassette 'E' - Fixed Rack 15 w/Std Divider R138R Montana Jack® Rigid R166 Explorer 5 R215 Probe WRS ACE™-UNC12 R245 Mirror Handle (Cone-Socket) R286 G2 Thin Composite R363S 113 Straight Serrated Cord Packer R375 Mixing Spatula/Applicator R386 38-39 Excavator T050 #5 Front Surface Mirror, Cone-Socket, (15/16') T040 Tweezers COLLEGE T046 Articulating paper forceps MILLER T235 Aspirating Anesthetic Syringe Medium T319 Bur Block T800 IRIS Scissors, curved FDA UDI
- Model / Reference
- R980 Crown and Bridge Kit FDA UDI
- Description
- Kit Includes: T015E-F FlipTop™ Cassette 'E' - Fixed Rack 15 w/Std Divider R138R Montana Jack® Rigid R166 Explorer 5 R215 Probe WRS ACE™-UNC12 R245 Mirror Handle (Cone-Socket) R286 G2 Thin Composite R363S 113 Straight Serrated Cord Packer R375 Mixing Spatula/Applicator R386 38-39 Excavator T050 #5 Front Surface Mirror, Cone-Socket, (15/16') T040 Tweezers COLLEGE T046 Articulating paper forceps MILLER T235 Aspirating Anesthetic Syringe Medium T319 Bur Block T800 IRIS Scissors, curved FDA UDI
Identifiers
- Catalog Number
- R980 FDA UDI
- Primary DI / UDI-DI
- 00813677024466 FDA UDI
- FDA Product Code
- DZN FDA UDIEAX FDA UDIFSM FDA UDIEMN FDA UDIEKB FDA UDIEIX FDA UDIEJB FDA UDIEGN FDA UDIEKH FDA UDIEIC FDA UDIEKC FDA UDIEJY 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, 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 25d0ddb7-e427-4762-bb79-4d9762829891 34 fields · synced Jun 9, 2026