Identity
- Trade Name
- ET Convertible Temporary Cylinder FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Model / Reference
- ETCTC400TCTH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810125996566 FDA UDI
- 510(k) Number
- K222636 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
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Dental implant suprastructure, temporary, preformed, single-use
The ET Convertible Temporary Cylinder is a prefabricated dental implant supportive device intended for temporary use during the oral soft-tissue healing and sculpting period prior to the fabrication/rehabilitation and installation of final prostheses/restorations. This single-use device features burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in various shapes, sizes, and materials.
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
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
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hiossen Inc.
Sources (1)
- FDA UDI b2172065-9c0b-4945-bbf3-16494cb753ea 33 fields · synced Jul 25, 2026