Identity
- Trade Name
- Ditron Dental FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Ti + PEEK Temporary Abutment CH4.0mm FDA UDI
- Model / Reference
- TAP-7504 FDA UDI
- Description
- Ti + PEEK Temporary Abutment CH4.0mm FDA UDI
Identifiers
- Catalog Number
- TAP-7504 FDA UDI
- Primary DI / UDI-DI
- 07290109287607 FDA UDI
- 510(k) Number
- K243066 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use 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
Dimensions & Sizes
- Size
- Height — 4.0 Millimeter FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-use
Ditron Dental by Ditron Dental Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
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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 96a20258-fe4f-4e7f-b657-256df54cd1ef 37 fields · synced Jun 1, 2026