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ET III SA Ultra-Wide Fixture Pre-Mounted
FDA UDIClass II (US FDA UDI)
by Hiossen Inc.
Identity
- Trade Name
- ET III SA Ultra-Wide Fixture Pre-Mounted FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Model / Reference
- AET3R7006S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814913020907 FDA UDI
- 510(k) Number
- K140934 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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 III SA Ultra-Wide Fixture Pre-Mounted by Hiossen Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Screw endosteal dental implant, two-piece.
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Cleared under the same submission
K140934 also covers:
- ET Healing Abutment — HIOSSEN INC.
- ET Healing Abutment — HIOSSEN INC.
- ET Healing Abutment — HIOSSEN INC.
- ET Healing Abutment — HIOSSEN INC.
- ET Healing Abutment — HIOSSEN INC.
- ET Healing Abutment — HIOSSEN INC.
- ET Healing Abutment Regular, 7.3(D), 6.0(H) — HIOSSEN INC.
- ET II Fixture SA Mini No-Mounted — HIOSSEN INC.
- ET II Fixture SA Mini No-Mounted — HIOSSEN INC.
- ET II Fixture SA Mini No-Mounted — HIOSSEN INC.
- ET II Fixture SA Mini No-Mounted — HIOSSEN INC.
- ET II Fixture SA Mini Pre-Mounted — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hiossen Inc.
Sources (1)
- FDA UDI f97c7c58-a388-473a-9dcf-b2e0fa9d8fcb 33 fields · synced May 31, 2026