e-Clean Fixture Mount
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- e-Clean Fixture Mount EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- DENTIS Implant Surgical Instrument System EUDAMEDDental Implant Instrument / e-Clean Fixture Mount FDA UDI
- Model / Reference
- DEFMW EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMEDDEFMMB EUDAMEDDEFMWB EUDAMEDDEFMM FDA UDI
- Description
- Dental Implant Instrument / e-Clean Fixture Mount FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806169135544 EUDAMEDFDA UDI08806169134646 EUDAMED08806169134660 EUDAMED08806169135520 FDA UDI
- Basic UDI-DI
- 88061691DENTIS-I7L EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental implant suprastructure, temporary, preformed, single-use
e-Clean Fixture Mount by Dentis Co. , Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dentis Co. , Ltd
Sources (5)
- FDA UDI cbbf9d9c-5148-43f2-8d59-1df719f1cde9 33 fields · synced Aug 1, 2026
- FDA UDI fc8059ec-2d20-4b33-9b20-4fdeb0fece57 33 fields · synced May 29, 2026
- EUDAMED 2ec7d049-203a-4925-af27-b865da68c696 61 fields · synced Jul 18, 2026
- EUDAMED 33efc439-d469-4141-9f16-f49ff9341caa 61 fields · synced Jul 26, 2026
- EUDAMED 8e7c68f9-8d1e-49d0-ad4f-e92232722db3 61 fields · synced Aug 1, 2026