← Back to catalogue
e-Clean Pick-Up Impression Coping
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref DEIW60HSModel DENTIS Implant Surgical Instrument SystemRef DEIW60HRef DEIR50NSRef DEIR50HRef DEIW60NRef DEIR60NSRef DEIR60H
Identity
- Trade Name
- e-Clean Pick-Up Impression Coping 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 Pick-Up Impression Coping FDA UDIe-Clean Pick-Up Impression Coping FDA UDI
- Model / Reference
- DEIR50NS EUDAMEDFDA UDIDEIW60HS EUDAMEDFDA UDIDEIR60NS EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMEDDEIW60H EUDAMEDDEIR50H EUDAMEDDEIW60N EUDAMEDDEIR60H EUDAMED
- Description
- Dental Implant Instrument / e-Clean Pick-Up Impression Coping FDA UDIe-Clean Pick-Up Impression Coping FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806169143761 EUDAMEDFDA UDI08806169143747 EUDAMEDFDA UDI08806169143778 EUDAMEDFDA UDI08806169142061 EUDAMED08806169142047 EUDAMED08806169142023 EUDAMED08806169142054 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 Pick-Up 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dentis Co. , Ltd
Sources (10)
- FDA UDI aab00922-99d1-46aa-ab25-6caf70afab73 33 fields · synced Aug 4, 2026
- FDA UDI 65b36ddb-9909-45cf-80c8-d39aef2b802d 33 fields · synced May 29, 2026
- FDA UDI b971f5ea-d089-4b13-9f9f-c7476fb4369b 33 fields · synced May 30, 2026
- EUDAMED ab3ee19c-f3a8-4d64-b20e-508c3abf3336 61 fields · synced Jul 9, 2026
- EUDAMED ef37eb83-a391-4f79-af8d-83a21736e72f 61 fields · synced Jul 14, 2026
- EUDAMED d1508b95-b7e2-457a-ac69-67dc651f27b0 61 fields · synced Jul 14, 2026
- EUDAMED dab36a76-b992-4539-9263-2741edfc6d76 61 fields · synced Jul 17, 2026
- EUDAMED 3f39a8c0-cc0a-4025-b4a2-9214936d2a37 61 fields · synced Jul 26, 2026
- EUDAMED d5c06030-e29f-4eb1-bbd4-d05138797b66 61 fields · synced Jul 28, 2026
- EUDAMED baba8fda-f8b7-4723-886e-b5f5c9f900c5 61 fields · synced Aug 4, 2026