s-Clean Multi Use Coping Screw
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- s-Clean Multi Use Coping Screw EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- DENTIS Implant Surgical Instrument System EUDAMEDs-Clean Multi Use Coping Screw (DSHHS02) FDA UDIDental Implant Instrument / s-Clean Multi Use Coping Screw FDA UDI
- Model / Reference
- DSHHS02 EUDAMEDFDA UDIDSMUCSN03 EUDAMEDFDA UDIDSMUCSN04 EUDAMEDFDA UDIDSMUCSN08 EUDAMEDFDA UDIDSMUCSN02 EUDAMEDFDA UDIDSHHS08 EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMEDDSHHSM04 EUDAMEDDSHHSM08 EUDAMEDDSHHSM06 EUDAMED
- Description
- s-Clean Multi Use Coping Screw (DSHHS02) FDA UDIDental Implant Instrument / s-Clean Multi Use Coping Screw FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806169156983 EUDAMEDFDA UDI08800053081757 EUDAMEDFDA UDI08800053081764 EUDAMEDFDA UDI08800053081788 EUDAMEDFDA UDI08800053081740 EUDAMEDFDA UDI08806169157041 EUDAMEDFDA UDI08800053092050 EUDAMED08800053092074 EUDAMED08800053092067 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
s-Clean Multi Use Coping Screw 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.
- 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
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 (15)
- FDA UDI 95157cab-0634-4d7e-92db-52dde3f949e8 33 fields · synced Aug 4, 2026
- FDA UDI cb919275-c687-4116-bcd9-8d55353c63fe 33 fields · synced May 24, 2026
- FDA UDI cca83a09-7776-4e76-931a-dcfc5e237aeb 33 fields · synced May 27, 2026
- FDA UDI 4b3e90f3-54b7-40d6-b072-fa78c66d6e5e 33 fields · synced May 30, 2026
- FDA UDI be3117cb-865a-41ce-a584-f245b3452c99 33 fields · synced May 30, 2026
- FDA UDI eda28113-ed62-4c4f-b681-4e8b89a6122a 33 fields · synced May 30, 2026
- EUDAMED 03c5b8aa-bd6d-407e-bff0-0caef3cf9aa4 61 fields · synced Jun 20, 2026
- EUDAMED 86abd3a3-cf30-4a71-814f-4d9e62beebf3 61 fields · synced Jul 9, 2026
- EUDAMED 6719dd40-918c-4b0a-867a-2dfd992d205d 61 fields · synced Jul 12, 2026
- EUDAMED 558fdae2-8f57-4ffd-847b-532c579a17b8 61 fields · synced Jul 17, 2026
- EUDAMED 39f31fb8-1ff3-4d0f-9854-1f023a50e945 61 fields · synced Jul 17, 2026
- EUDAMED b5904a18-2b1e-41f6-8763-e7a833e3ec82 61 fields · synced Jul 18, 2026
- EUDAMED c17f7730-b400-42d9-9ffe-bb08a928c2e5 61 fields · synced Jul 25, 2026
- EUDAMED 44614dfd-2e6d-4fef-bb82-5dcb749f3df7 61 fields · synced Jul 26, 2026
- EUDAMED b4268d5e-8c73-48e8-845a-d973d5b8f67f 61 fields · synced Aug 4, 2026