Identity
- Trade Name
- PDT, Inc. FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Kit Includes: T015E-U FlipTop™ Cassette 'E' - Utility T120 Luxating instrument-2 T121 Luxating instrument-3 T108 Root elevator CRYER 39 T109 Root elevator CRYER 40 T790 Extracting forceps 150 extra grip T792 Extracting forceps 151 extra grip T794 Extracting forceps 23 Cowhorn T714 TC Needle Holder CRILE WOOD T820 Scissors La-Grange 11.5 FDA UDI
- Model / Reference
- R911 PDT Mission Surgical Extraction Kit FDA UDI
- Description
- Kit Includes: T015E-U FlipTop™ Cassette 'E' - Utility T120 Luxating instrument-2 T121 Luxating instrument-3 T108 Root elevator CRYER 39 T109 Root elevator CRYER 40 T790 Extracting forceps 150 extra grip T792 Extracting forceps 151 extra grip T794 Extracting forceps 23 Cowhorn T714 TC Needle Holder CRILE WOOD T820 Scissors La-Grange 11.5 FDA UDI
Identifiers
- Catalog Number
- R911 FDA UDI
- Primary DI / UDI-DI
- 00813677024817 FDA UDI
- FDA Product Code
- FSM FDA UDIEMJ FDA UDIDZN FDA UDIEMG FDA UDIEGN FDA UDIHXK FDA UDIEMO FDA UDI
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI872.4565 FDA UDI888.4540 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, reusableSuturing needle holder, reusableDental elevator, tooth/rootTooth extraction forceps
PDT, Inc. by PDT, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Periotome, reusable.
- Luxator — Directa AB · Class I
- A. Titan Instruments — A.Titan Instruments · Class I
- devemed — devemed GmbH · Class I
- STOMA® — Storz am Mark GmbH · Class I
- KOHDENT — Kohler Medizintechnik GmbH & Co. KG · Class I
- Power Dental USA — Power Dental USA, Inc. · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Power Dental USA — Power Dental USA, Inc. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PDT, Inc.
Sources (1)
- FDA UDI 2e3f9628-cd01-4e6d-b2fa-b4b501f4599c 34 fields · synced Jun 9, 2026