Identity
- Trade Name
- Power Dental U.S.A., Inc. FDA UDI
- Generic Name
- Intraoperative orthopaedic bone pin/screw, single-use FDA UDI
- Device Name
- POWER PROSTHETIC KIT 1.2mm: Ankylos,Neobiotech, Dio, Hiossen/Ostem, Megagen.1.25mm: Astra, Dentium, Zimmer.1.3mm: Japan .etc.B/M: Branemark. Nobel Biocare.S/M: Straumann. FDA UDI
- Model / Reference
- N7813N FDA UDI
- Description
- POWER PROSTHETIC KIT 1.2mm: Ankylos,Neobiotech, Dio, Hiossen/Ostem, Megagen.1.25mm: Astra, Dentium, Zimmer.1.3mm: Japan .etc.B/M: Branemark. Nobel Biocare.S/M: Straumann. FDA UDI
Identifiers
- Catalog Number
- N7813N FDA UDI
- Primary DI / UDI-DI
- D943N7813N00 FDA UDI
- FDA Product Code
- HWD FDA UDI
- GMDN Term
- Intraoperative orthopaedic bone pin/screw, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Intraoperative orthopaedic bone pin/screw, single-use
Power Dental U.S.A., Inc. by Power Dental USA, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intraoperative orthopaedic bone pin/screw, single-use.
- EVOS — Smith & Nephew, Inc. · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class II
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- LIF-PTP — ALPHATEC SPINE, 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
- Power Dental USA, Inc.
Sources (1)
- FDA UDI 4949cf63-4443-4a75-bd2b-b23653a31742 35 fields · synced May 29, 2026