Identity
- Trade Name
- ET Rigid Abutment SET FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Model / Reference
- ETRA7650CP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810125990946 FDA UDI
- 510(k) Number
- K222636 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Screw endosteal dental implant, two-piece 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
No
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
Category: Screw endosteal dental implant, two-piece
ET Rigid Abutment SET by Hiossen Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Screw endosteal dental implant, two-piece.
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Cleared under the same submission
K222636 also covers:
- ET Angled Abutment — HIOSSEN INC.
- ET Angled Abutment — HIOSSEN INC.
- ET Angled Abutment — HIOSSEN INC.
- ET Angled Abutment Set — HIOSSEN INC.
- ET Cerec Scan Body — HIOSSEN INC.
- ET Convertible Abutment — HIOSSEN INC.
- ET Convertible Pick-up Guide Pin — HIOSSEN INC.
- ET Convertible Plastic Cylinder — HIOSSEN INC.
- ET Convertible Temporary Cylinder — HIOSSEN INC.
- ET FIXTURE PICK-UP IMPRESSION COPING — HIOSSEN INC.
- ET FIXTURE TRANSFER IMPRESSION COPING — HIOSSEN INC.
- ET FIXTURE TRANSFER IMPRESSION COPING — HIOSSEN INC.
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
- Hiossen Inc.
Sources (1)
- FDA UDI 075c61a2-5f27-4190-9f90-f92c9de54aee 33 fields · synced May 31, 2026