Identity
- Trade Name
- DESS dental smart solutions FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Internal Hex "Click" FDA UDI
- Model / Reference
- 88011/4 FDA UDI
- Description
- Internal Hex "Click" FDA UDI
Identifiers
- Catalog Number
- 88011/4 FDA UDI
- Primary DI / UDI-DI
- 08435457210108 FDA UDI
- 510(k) Number
- K170588 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant suprastructure, permanent, preformed
DESS dental smart solutions by Terrats Medical Sl. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
- HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
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- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class II
Cleared under the same submission
K170588 also covers:
- ArgenIS — ARGEN CORPORATION, THE
- ArgenIS — ARGEN CORPORATION, THE
- ArgenIS — ARGEN CORPORATION, THE
- ArgenIS — ARGEN CORPORATION, THE
- ArgenIS — ARGEN CORPORATION, THE
- ArgenIS — ARGEN CORPORATION, THE
- ArgenIS — ARGEN CORPORATION, THE
- ArgenIS — ARGEN CORPORATION, THE
- Preat — PREAT Corporation
- Preat — PREAT Corporation
- Preat — PREAT Corporation
- Preat — PREAT Corporation
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
- Terrats Medical Sl.
Sources (1)
- FDA UDI 75531c40-9416-4638-9547-c887ab213203 36 fields · synced May 30, 2026