Identity
- Trade Name
- ET RIGID RETRACTION CAP FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Model / Reference
- ETRRC660 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810019240324 FDA UDI
- 510(k) Number
- K161689 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-use
Et Rigid Retraction Cap by Hiossen Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
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- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
Cleared under the same submission
K161689 also covers:
- ET FREEFORM ST ABUTMENT — HIOSSEN INC.
- ET FREEFORM ST ABUTMENT — HIOSSEN INC.
- ET FREEFORM ST ABUTMENT — HIOSSEN INC.
- ET STUD ABUTMENT SET — HIOSSEN INC.
- ET ZIOCERA ABUTMENT — HIOSSEN INC.
- Screw-Multi Angled ABT — HIOSSEN INC.
- OSSTEM Implant System - Abutment — OSSTEM IMPLANT Co., Ltd.
- OSSTEM Implant System - Abutment — OSSTEM IMPLANT Co., Ltd.
- OSSTEM Implant System - Abutment — OSSTEM IMPLANT Co., Ltd.
- OSSTEM Implant System - Abutment — OSSTEM IMPLANT Co., Ltd.
- OSSTEM Implant System - Abutment — OSSTEM IMPLANT Co., Ltd.
- OSSTEM Implant System - Abutment — OSSTEM IMPLANT Co., 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 I | Pending data |
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Manufacturer
- Manufacturer
- Hiossen Inc.
Sources (1)
- FDA UDI fb680b86-8d50-40cc-87cf-cbf873794527 33 fields · synced May 30, 2026