Identity
- Trade Name
- M.A.R.A Torquing Tool FDA UDI
- Generic Name
- Dental torque wrench FDA UDI
- Model / Reference
- 900600 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D8199006000 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
M.A.R.A Torquing Tool 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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- Restore — Keystone Dental Inc. · Class I
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- 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 a54c4e53-3920-454c-b6af-ce77d576d772 32 fields · synced May 30, 2026