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e-Clean Transfer Impression Coping
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref DETIW60NSModel DENTIS Implant Surgical Instrument SystemRef DETIW60NRef DETIR60HRef DETIR50NRef DETIR60NSRef DETIW60HSRef DETIR50NSRef DETIR60N
Identity
- Trade Name
- e-Clean Transfer Impression Coping EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- DENTIS Implant Surgical Instrument System EUDAMEDe-Clean Transfer Impression Coping FDA UDIDental Implant Instrument / e-Clean Transfer Impression Coping FDA UDI
- Model / Reference
- DETIW60HS EUDAMEDFDA UDIDETIR60NS EUDAMEDFDA UDIDETIR50NS EUDAMEDFDA UDIDETIW60NS EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMEDDETIW60N EUDAMEDDETIR60H EUDAMEDDETIR50N EUDAMEDDETIR60N EUDAMED
- Description
- e-Clean Transfer Impression Coping FDA UDIDental Implant Instrument / e-Clean Transfer Impression Coping FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806169143860 EUDAMEDFDA UDI08806169143839 EUDAMEDFDA UDI08806169143815 EUDAMEDFDA UDI08806169143853 EUDAMEDFDA UDI08806169142108 EUDAMED08806169142139 EUDAMED08806169142085 EUDAMED08806169142092 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-use
e-Clean Transfer Impression Coping 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
European Union Unknown
MDR
United States Pending data
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 (12)
- FDA UDI 1ee1331c-fe14-4201-8078-e787cd80b999 33 fields · synced Sep 18, 2026
- FDA UDI f46ec26c-a36c-47a4-9d0d-9f374d98dd3f 33 fields · synced May 27, 2026
- FDA UDI 1c4fa45c-a43b-413b-a449-ccba8d389ea6 33 fields · synced May 30, 2026
- FDA UDI 82c9bd58-7511-492c-aef4-cfb631a65cec 33 fields · synced May 30, 2026
- EUDAMED 7b8bb47e-6c72-48e9-bcfa-23b269984093 61 fields · synced Jul 10, 2026
- EUDAMED ae3114dc-6900-4002-bb9a-4284a8da7dcf 61 fields · synced Jul 11, 2026
- EUDAMED 10fcd554-c0da-445c-8462-4a19cd9c23dd 61 fields · synced Jul 11, 2026
- EUDAMED c129f854-1b0e-49ac-8fe4-dc24aa230f5c 61 fields · synced Jul 13, 2026
- EUDAMED bf537961-73a8-48a7-8be7-48a2b31bb5e7 61 fields · synced Jul 14, 2026
- EUDAMED 316179a0-be52-499f-96ed-82c914b2adc4 61 fields · synced Aug 1, 2026
- EUDAMED b5479d5c-e300-4647-8665-bca7f83d40a5 61 fields · synced Aug 3, 2026
- EUDAMED 80285374-abdd-4563-8301-2d9855ba5287 61 fields · synced Sep 18, 2026