Identity
- Trade Name
- WP Angled Single TMA 30° 4mm FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Model / Reference
- WP3738S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290109309095 FDA UDI
- 510(k) Number
- K112585 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental implant suprastructure, permanent, preformed
WP Angled Single TMA 30° 4mm by Adin Dental Implant Systems Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K112585 also covers:
- C-Type Ti Base RP Abutment, GH 3mm Non Engaged — ADIN DENTAL IMPLANT SYSTEMS LTD
- C-Type Ti Base WP Abutment, GH 4mm Non Engaged — ADIN DENTAL IMPLANT SYSTEMS LTD
- Grip WP Angled Abutment 15°, GH 5mm — ADIN DENTAL IMPLANT SYSTEMS LTD
- IRIS™ RP CloseFit™ Kit, RH 4mm GH 1mm — ADIN DENTAL IMPLANT SYSTEMS LTD
- IRIS™ WP CloseFit™ Kit, RH 6mm GH 1mm — ADIN DENTAL IMPLANT SYSTEMS LTD
- IRIS™ WP Kit, RH 8mm GH 4mm — ADIN DENTAL IMPLANT SYSTEMS LTD
- RP Ball Attachment 2mm — ADIN DENTAL IMPLANT SYSTEMS LTD
- RP CloseFit™ Ti Base Angular Engaged — ADIN DENTAL IMPLANT SYSTEMS LTD
- RP Conical Implant Cover Screw — ADIN DENTAL IMPLANT SYSTEMS LTD
- RP Engaging temporary abutment — ADIN DENTAL IMPLANT SYSTEMS LTD
- RP Flat Connection Abutment 4mm — ADIN DENTAL IMPLANT SYSTEMS LTD
- RP Implant Cover Screw — ADIN DENTAL IMPLANT SYSTEMS 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 |
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Manufacturer
- Manufacturer
- Adin Dental Implant Systems Ltd
Sources (1)
- FDA UDI 48dba9c7-1b2e-459c-8298-ab4298ef11e4 33 fields · synced May 30, 2026