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i-Clean Pick-Up Impression Coping
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref DIPIRZModel DENTIS Implant Surgical Instrument SystemRef DIPIWNRef DIPIWSRef DIPIRZSRef DIPIWZRef DIPISZ60SRef DIPIWZSRef DIPIS60Ref DIPIWNZ
Identity
- Trade Name
- i-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 / i-Clean Pick-Up Impression Coping FDA UDI
- Model / Reference
- DIPIWS EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMEDDIPIRZ EUDAMEDDIPIWN EUDAMEDDIPIRZS EUDAMEDDIPIWZ EUDAMEDDIPISZ60S EUDAMEDDIPIWZS EUDAMEDDIPIS60 EUDAMEDDIPIWNZ EUDAMEDDIPIRS FDA UDI
- Description
- Dental Implant Instrument / i-Clean Pick-Up Impression Coping FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806169143570 EUDAMEDFDA UDI08800053033749 EUDAMED08806169141842 EUDAMED08800053033930 EUDAMED08800053033763 EUDAMED08800053033947 EUDAMED08800053033954 EUDAMED08806169141811 EUDAMED08800053033787 EUDAMED08806169143556 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDIFDA 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
i-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 |
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Manufacturer
- Manufacturer
- Dentis Co. , Ltd
Sources (11)
- FDA UDI c08027a6-0c18-44fa-a908-a754a09a2907 33 fields · synced Jul 30, 2026
- FDA UDI 7eb38d6b-0686-40c1-883a-acc5d09a9866 33 fields · synced May 30, 2026
- EUDAMED 950cadfa-2c5d-43c2-8db1-71239c1a87b2 61 fields · synced Jun 20, 2026
- EUDAMED 92ed6cbd-0bf7-4d1c-9239-a01810170d7f 61 fields · synced Jul 13, 2026
- EUDAMED 435b8412-d04d-4c7a-b1bb-87d9e541b2bd 61 fields · synced Jul 19, 2026
- EUDAMED 37246bce-9848-49b9-8156-df6832bec247 61 fields · synced Jul 20, 2026
- EUDAMED 037b54d5-bbb7-4aa5-a868-bfc5b753ddea 61 fields · synced Jul 21, 2026
- EUDAMED d8ad3cf8-3eda-444d-90fc-bec9fe2dcbe6 61 fields · synced Jul 22, 2026
- EUDAMED b39f101b-79ba-49f5-83a2-290af753408d 61 fields · synced Jul 22, 2026
- EUDAMED c0e06557-9fb3-4916-af9c-5559bad664dc 61 fields · synced Jul 24, 2026
- EUDAMED 0740aca1-684a-46cf-8be7-681a11c84720 61 fields · synced Jul 30, 2026