e-Clean Fixture Short Mount
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- e-Clean Fixture Short 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 Short Mount FDA UDI
- Model / Reference
- DEFMSR EUDAMEDFDA UDIDEFMSM EUDAMEDFDA UDIDEFMSW EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMEDDEFMSRB EUDAMEDDEFMSWB EUDAMED
- Description
- Dental Implant Instrument / e-Clean Fixture Short Mount FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806169140104 EUDAMEDFDA UDI08806169140098 EUDAMEDFDA UDI08806169140111 EUDAMEDFDA UDI08806169139634 EUDAMED08806169139641 EUDAMED
- 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 Short 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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- Neoss Implant System — Neoss, Ltd. · Class II
- 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 (8)
- FDA UDI 63ab9900-02a8-49de-a85d-6a806f53a221 33 fields · synced Aug 3, 2026
- FDA UDI d59c766d-4196-481a-a471-5483767efe2f 33 fields · synced May 30, 2026
- FDA UDI 86038b5f-e92a-4bfd-934f-8abbb4290cd0 33 fields · synced May 30, 2026
- EUDAMED 884d218f-5e1d-4fbb-9645-8e6ceb97d58f 61 fields · synced Jul 9, 2026
- EUDAMED ff10f7c3-58b6-45f9-8436-bcc438a765ca 61 fields · synced Jul 10, 2026
- EUDAMED 8320b55e-18b8-47ba-9edd-046453042806 61 fields · synced Jul 22, 2026
- EUDAMED 0a0c564b-6a63-4f57-8f32-301e270d30a4 61 fields · synced Jul 24, 2026
- EUDAMED daa4d356-fd2b-4d10-88f5-6aa1895464f5 61 fields · synced Aug 3, 2026