Identity
- Trade Name
- IRIS™, RS Abutment, RH 4mm GH 3mm FDA UDI
- Generic Name
- Dental implant suprastructure kit FDA UDI
- Model / Reference
- IR0443 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290109302645 FDA UDI
- 510(k) Number
- K081751 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure kit 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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 kit
IRIS™, RS Abutment, RH 4mm GH 3mm by Adin Dental Implant Systems Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure kit.
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- KLOCKNER — SOADCO, S.L. · Class II
- CERALOG® PL Abutment 15° angled, Ø 3.8 mm, GH 1.0 mm — CeramTec Schweiz GmbH · Class II
- KLOCKNER — SOADCO, S.L. · Class II
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD · Class II
- KLOCKNER — SOADCO, S.L. · Class II
Cleared under the same submission
K081751 also covers:
- C-Type Ti Base RS Abutment, GH 1mm Non Engaged — ADIN DENTAL IMPLANT SYSTEMS LTD
- 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 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 a2b38e97-a1a3-49df-ab7a-24fa7838e28b 33 fields · synced Jun 1, 2026