Identity
- Trade Name
- INFINTY EXTERNAL HEX SYSTEM FDA UDI
- Generic Name
- Screw endosteal dental implant, one-piece FDA UDI
- Device Name
- INTERNAL HEX MULTI-UNIT ABUTMENT 3.5 PLATFORM X3MM H. 17 DEG ANG FDA UDI
- Model / Reference
- 20351703 FDA UDI
- Description
- INTERNAL HEX MULTI-UNIT ABUTMENT 3.5 PLATFORM X3MM H. 17 DEG ANG FDA UDI
Identifiers
- Catalog Number
- 20351703 FDA UDI
- Primary DI / UDI-DI
- 00614950027316 FDA UDI
- 510(k) Number
- K103790 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Screw endosteal dental implant, one-piece 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 3 Millimeter FDA UDI
Category: Screw endosteal dental implant, one-piece
The INFINTY EXTERNAL HEX SYSTEM is a premium, one-piece screw endosteal dental implant used to support and retain dental prosthesis in the mandible or maxilla. Designed for optimal comfort and functionality, this implant provides a secure anchor point for various types of dental restorations.
Similar devices
Also classified as Screw endosteal dental implant, one-piece.
- KJ Mini Implant System — Kj Meditech · Class II
- VERSALIS S PLUS — S.I.N. - Sistema DE Implante Nacional S.A. · Class II
- Zirlux — HENRY SCHEIN, INC. · Class II
- KLOCKNER — SOADCO, S.L. · Class II
- Tryon — S.I.N. - Sistema DE Implante Nacional S.A. · Class II
- KJ Mini Implant System — Kj Meditech · Class II
- Advanced Intermezzo Fixture — Megagen Implant Co. Ltd · Class II
- OT-F2 Prosthetics — OT medical GmbH · Class II
Cleared under the same submission
K103790 also covers:
- ACE — ACE SURGICAL SUPPLY CO., INC.
- ACE — ACE SURGICAL SUPPLY CO., INC.
- ACE — ACE SURGICAL SUPPLY CO., INC.
- ACE — ACE SURGICAL SUPPLY CO., INC.
- Hexagon — ACE SURGICAL SUPPLY CO., INC.
- INFINTY EXTERNAL HEX SYSTEM — ACE SURGICAL SUPPLY CO., INC.
- INFINTY EXTERNAL HEX SYSTEM — ACE SURGICAL SUPPLY CO., INC.
- INFINTY EXTERNAL HEX SYSTEM — ACE SURGICAL SUPPLY CO., INC.
- INFINTY EXTERNAL HEX SYSTEM — ACE SURGICAL SUPPLY CO., INC.
- INFINTY EXTERNAL HEX SYSTEM — ACE SURGICAL SUPPLY CO., INC.
- INFINTY EXTERNAL HEX SYSTEM — ACE SURGICAL SUPPLY CO., INC.
- INFINTY EXTERNAL HEX 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 1d059162-8aef-4871-8d98-5d631b619f10 37 fields · synced Jul 11, 2026