Identity
- Trade Name
- miniMark Dental Implant System FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- miniMARK 2.3X11.5MM W/4MM CUFF LOCATOR IMPLANT TI6AL 4V ELI FDA UDI
- Model / Reference
- 10231140 FDA UDI
- Description
- miniMARK 2.3X11.5MM W/4MM CUFF LOCATOR IMPLANT TI6AL 4V ELI FDA UDI
Identifiers
- Catalog Number
- 10231140 FDA UDI
- Primary DI / UDI-DI
- 00614950003075 FDA UDI
- 510(k) Number
- K092594 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 11.5 Millimeter FDA UDI
Category: Dental implant suprastructure, permanent, preformed
miniMark Dental Implant System by Ace Surgical Supply Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
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Cleared under the same submission
K092594 also covers:
- miniMark Dental Implant System — ACE SURGICAL SUPPLY CO., INC.
- miniMark Dental Implant System — ACE SURGICAL SUPPLY CO., INC.
- miniMark Dental Implant System — ACE SURGICAL SUPPLY CO., INC.
- miniMark Dental Implant System — ACE SURGICAL SUPPLY CO., INC.
- miniMark Dental Implant System — ACE SURGICAL SUPPLY CO., INC.
- miniMark Dental Implant System — ACE SURGICAL SUPPLY CO., INC.
- miniMark Dental Implant System — ACE SURGICAL SUPPLY CO., INC.
- miniMark Dental Implant System — ACE SURGICAL SUPPLY CO., INC.
- miniMark Dental Implant System — ACE SURGICAL SUPPLY CO., INC.
- miniMark Dental Implant System — ACE SURGICAL SUPPLY CO., INC.
- miniMark Dental Implant System — ACE SURGICAL SUPPLY CO., INC.
- miniMark Dental Implant System — ACE SURGICAL SUPPLY CO., INC.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Ace Surgical Supply Co., Inc.
Sources (1)
- FDA UDI 9b32bfba-164e-488d-952e-2ad7a89a5249 37 fields · synced Jun 6, 2026