Identity
- Trade Name
- Plastic Ball Cap White FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Model / Reference
- RS2660 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290105154774 FDA UDI
- 510(k) Number
- K081751 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-use
Plastic Ball Cap White by Adin Dental Implant Systems 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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Cleared under the same submission
K081751 also covers:
- C-Type Ti Base RS Abutment, GH 3mm Engaged — ADIN DENTAL IMPLANT SYSTEMS LTD
- C-Type Ti Base RS Abutment, GH 4mm Engaged Wide — ADIN DENTAL IMPLANT SYSTEMS LTD
- C-Type Ti Base RS Abutment, GH 4mm Non Engaged Wide — ADIN DENTAL IMPLANT SYSTEMS LTD
- Grip Extended Range Retention - Extra Light (Red), 4 pack — ADIN DENTAL IMPLANT SYSTEMS LTD
- Grip RS Angled Abutment 15°, GH 3mm — ADIN DENTAL IMPLANT SYSTEMS LTD
- Grip Retention - Light (Pink), 4 pack — ADIN DENTAL IMPLANT SYSTEMS LTD
- Grip housing, 4 pack — ADIN DENTAL IMPLANT SYSTEMS LTD
- Grip processing set (Blue & Pink) — ADIN DENTAL IMPLANT SYSTEMS LTD
- IRIS™, RS Abutment, RH 4mm GH 2mm — ADIN DENTAL IMPLANT SYSTEMS LTD
- IRIS™, RS Abutment, RH 4mm GH 3mm — ADIN DENTAL IMPLANT SYSTEMS LTD
- IRIS™, RS Abutment, RH 6mm GH 4mm — ADIN DENTAL IMPLANT SYSTEMS LTD
- IRIS™, RS Kit, RH 6mm GH 1mm — 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 5df53844-c135-4366-b0c9-773714e9756d 33 fields · synced Jun 8, 2026