Identity
- Trade Name
- Athena Champion FDA UDI
- Generic Name
- Dental mandrel FDA UDI
- Device Name
- Athena Champion Metal Mandrel 14mm, Latch Type, CE FDA UDI
- Model / Reference
- 282412 FDA UDI
- Description
- Athena Champion Metal Mandrel 14mm, Latch Type, CE FDA UDI
Identifiers
- Catalog Number
- 282412 FDA UDI
- Primary DI / UDI-DI
- 00302732824122 FDA UDI
- 510(k) Number
- K790722 FDA UDI
- FDA Product Code
- EGS FDA UDI
- GMDN Term
- Dental mandrel 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental mandrel
Athena Champion by Young Dental Manufacturing I, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental mandrel.
- Preat — PREAT Corporation · Class I
- KOMET Abrasive Disc — Gebr. Brasseler GmbH & Co. KG · Class I
- KOMET Abrasive Disc — Gebr. Brasseler GmbH & Co. KG · Class I
- Johnson-Promident — Young Innovations, Inc. · Class I
- CEKA & PRECI-LINE ATTACHMENTS — Alpha-Dent · Class I
- CEKA & PRECI-LINE ATTACHMENTS — Alpha-Dent · Class I
- CEKA & PRECI-LINE ATTACHMENTS — Alpha-Dent · Class I
- Preat — PREAT Corporation · Class I
Cleared under the same submission
K790722 also covers:
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
- Young Dental Manufacturing I, Llc
Sources (1)
- FDA UDI c0bff56f-8fc3-4d80-9b8c-32fe6a0daef5 36 fields · synced May 30, 2026