Identity
- Trade Name
- Contra Angle 32:1 FDA UDI
- Generic Name
- Line-powered dental drilling/sawing system handpiece FDA UDI
- Device Name
- Contra Angle 32:1 FDA UDI
- Model / Reference
- 5054NOU FDA UDI
- Description
- Contra Angle 32:1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- ENOU5054NOU0 FDA UDI
- 510(k) Number
- K022505 FDA UDI
- FDA Product Code
- EGS FDA UDI
- GMDN Term
- Line-powered dental drilling/sawing system handpiece FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Line-powered dental drilling/sawing system handpiece
Contra Angle 32:1 by Nouvag AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Line-powered dental drilling/sawing system handpiece.
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Cleared under the same submission
K022505 also covers:
- Clip for Contra Angle — Nouvag AG
- Clip for Contra Angle 20:1 LED — Nouvag AG
- Clip for internal cooling — Nouvag AG
- Clip for internal irrigation needle for Contra Angle — Nouvag AG
- Clip for internal irrigation needle for Contra Angle 20:1 — Nouvag AG
- Contra Angle 16:1 — Nouvag AG
- Contra Angle 16:1 Endodontics — Nouvag AG
- Contra Angle 1:1 — Nouvag AG
- Contra Angle 1:1 — Nouvag AG
- Contra Angle 20:1 — Nouvag AG
- Contra Angle 20:1 LED — Nouvag AG
- Contra Angle 20:1 Mini — Nouvag AG
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
- Nouvag AG
Sources (1)
- FDA UDI cdc700c4-fe00-4eae-a360-c80001c044ee 35 fields · synced May 31, 2026