Identity
- Trade Name
- Ditron Dental FDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw FDA UDI
- Device Name
- CC Prosthetic Screw 1.25 Hex FDA UDI
- Model / Reference
- ABTS-3000 FDA UDI
- Description
- CC Prosthetic Screw 1.25 Hex FDA UDI
Identifiers
- Catalog Number
- ABTS-3000 FDA UDI
- Primary DI / UDI-DI
- 07290109284736 FDA UDI
- 510(k) Number
- K243066 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental prosthesis/implant abutment screw 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental prosthesis/implant abutment screw
Ditron Dental by Ditron Dental Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis/implant abutment screw.
- Azure — TERRATS MEDICAL SL. · Class II
- Inclusive — PRISMATIK DENTALCRAFT, INC. · Class II
- KLOCKNER — SOADCO, S.L. · Class II
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL · Class II
- Implant Prosthetics — PREAT Corporation · Class II
- INNO Submerged Implant System-Cemented Abutment — Cowellmedi Co., Ltd · Class II
- MEDENTiKA — Medentika GmbH · Class II
- Azure — TERRATS MEDICAL SL. · Class II
Cleared under the same submission
K243066 also covers:
- Ditron Dental — DITRON DENTAL LTD
- Ditron Dental — DITRON DENTAL LTD
- Ditron Dental — DITRON DENTAL LTD
- Ditron Dental — DITRON DENTAL LTD
- Ditron Dental — DITRON DENTAL LTD
- Ditron Dental — DITRON DENTAL LTD
- Ditron Dental — DITRON DENTAL LTD
- Ditron Dental — DITRON DENTAL LTD
- Ditron Dental — DITRON DENTAL LTD
- Ditron Dental — DITRON DENTAL LTD
- Ditron Dental — DITRON DENTAL LTD
- Ditron Dental — DITRON DENTAL LTD
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ditron Dental Ltd
Sources (1)
- FDA UDI 97c29f6c-e63a-4e6a-b1d7-a971c70801c7 36 fields · synced May 30, 2026