Identity
- Trade Name
- Hexagon FDA UDI
- Generic Name
- Screw endosteal dental implant, one-piece FDA UDI
- Device Name
- NP Straight Healing Abutment, D 3.7 mm, H 5.0 mm FDA UDI
- Model / Reference
- 1312063 FDA UDI
- Description
- NP Straight Healing Abutment, D 3.7 mm, H 5.0 mm FDA UDI
Identifiers
- Catalog Number
- 1312063 FDA UDI
- Primary DI / UDI-DI
- 00614950015894 FDA UDI
- 510(k) Number
- K102981 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Screw endosteal dental implant, one-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
- Height — 5 Millimeter FDA UDI
Category: Screw endosteal dental implant, one-piece
Hexagon by Ace Surgical Supply Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
K102981 also covers:
- ACE — ACE SURGICAL SUPPLY CO., INC.
- ACE — ACE SURGICAL SUPPLY CO., INC.
- Hexagon — ACE SURGICAL SUPPLY CO., INC.
- Hexagon — ACE SURGICAL SUPPLY CO., INC.
- Hexagon — ACE SURGICAL SUPPLY CO., INC.
- Hexagon — ACE SURGICAL SUPPLY CO., INC.
- Hexagon — ACE SURGICAL SUPPLY CO., INC.
- Hexagon — ACE SURGICAL SUPPLY CO., INC.
- Hexagon — ACE SURGICAL SUPPLY CO., INC.
- Hexagon — ACE SURGICAL SUPPLY CO., INC.
- Hexagon — ACE SURGICAL SUPPLY CO., INC.
- Hexagon — 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 c30c48b6-f948-414e-b98d-143f583e3fa0 37 fields · synced Jun 8, 2026