Identity
- Trade Name
- PDT, Inc. FDA UDI
- Generic Name
- Manual non-rotary dental instrument handle FDA UDI
- Device Name
- Kit Includes: (T015E-F) E-Series FlipTop™ Cassette - Fixed Rack 15 with Standard Divider (R077) Younger-Good 7-8 (R226) 23 Explorer-UNC15 Probe (R245) Cone Socket Mirror Handle (R442) Periosteal Elevator (2mm) (R443) Periosteal Elevator (3mm) (R444) End Cutting Intrasulcular Knife (R445) Modified Orban Knife (T050) #5 Mirror (15/16") (T084) Corn Suture Pliers (T086) Micro Straight Pliers (17.5cm) (T088) Castroviejo Straight Tungsten Carbide Needle Holder (17.5cm) (T705) Adjustable Scalpel Handle (T813) Goldman-Fox Curved Scissors (12.5cm) FDA UDI
- Model / Reference
- R927 PDT Tissue Grafting Kit FDA UDI
- Description
- Kit Includes: (T015E-F) E-Series FlipTop™ Cassette - Fixed Rack 15 with Standard Divider (R077) Younger-Good 7-8 (R226) 23 Explorer-UNC15 Probe (R245) Cone Socket Mirror Handle (R442) Periosteal Elevator (2mm) (R443) Periosteal Elevator (3mm) (R444) End Cutting Intrasulcular Knife (R445) Modified Orban Knife (T050) #5 Mirror (15/16") (T084) Corn Suture Pliers (T086) Micro Straight Pliers (17.5cm) (T088) Castroviejo Straight Tungsten Carbide Needle Holder (17.5cm) (T705) Adjustable Scalpel Handle (T813) Goldman-Fox Curved Scissors (12.5cm) FDA UDI
Identifiers
- Catalog Number
- R927 FDA UDI
- Primary DI / UDI-DI
- 00813677024916 FDA UDI
- FDA Product Code
- EAX FDA UDIFSM FDA UDIEMS FDA UDIEKB FDA UDIEIX FDA UDIEJB FDA UDIEMJ FDA UDIEMO FDA UDIGDZ FDA UDIEJY FDA UDIEGN FDA UDIHXK FDA UDI
- GMDN Term
- Manual non-rotary dental instrument handle FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI878.4800 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, reusableSurgical soft-tissue manipulation forceps, tweezers-like, reusablePeriosteal elevator, 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 70169b0a-baa2-482e-bc17-78ff5cdf508e 34 fields · synced Jun 9, 2026