Identity
- Trade Name
- Ball-End Hex Wrench FDA UDI
- Generic Name
- Dental torque wrench FDA UDI
- Model / Reference
- 900585 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D8199005850 FDA UDI
- FDA Product Code
- DZN FDA UDI
- GMDN Term
- Dental torque wrench FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental torque wrench
Ball-End Hex Wrench by Specialty Appliances, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental torque wrench.
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- Torque Wrench — Elos Medtech Pinol A/S · Class I
- Restore — Keystone Dental Inc. · Class I
- RS 2.45 Hex Handpiece Adapter FLX - Short — ADIN DENTAL IMPLANT SYSTEMS LTD · Class I
- Azure — TERRATS MEDICAL SL. · Class I
- Graduated Torque Wrench — Sterngold Dental LLC · Class I
- SURGICAL TORQUE RATCHET — S.I.N. - Sistema DE Implante Nacional S.A. · Class I
- DESS dental smart solutions — TERRATS MEDICAL SL. · 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 |
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Manufacturer
- Manufacturer
- Specialty Appliances, Llc
Sources (1)
- FDA UDI c2ca7e06-ce1e-4f45-8751-f2ff33c91768 32 fields · synced May 30, 2026