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s-Clean Multi Use Coping Healing Cap
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref DSMUCM4544SModel DENTIS Implant Surgical Instrument SystemRef DSMUC4584Ref DSMUC5564SRef DSMUC4524Ref DSMUC5584SRef DSMUC6544Ref DSMUC5584Ref DSMUCN4564SRef DSMUC6524SRef DSMUCM4534SRef DSHIHC55Ref DSMUCM5544SRef DSMUC4544SRef DSHIHC45Ref DSMUCM4564SRef DSMUC6564Ref DSMUCN4524Ref DSMUC5524SRef DSMUC4534SRef DSMUCM4584Ref DSMUC5564Ref DSMUC6584SRef DSMUCM4564Ref DSMUCM5534Ref DSMUC4534Ref DSMUCM5534SRef DSMUC5534SRef DSMUCM5544Ref DSMUCM4524Ref DSMUC5534Ref DSMUCN4534Ref DSMUCN4584SRef DSMUC5544Ref DSMUCM5564S
Identity
- Trade Name
- s-Clean Multi Use Coping Healing Cap EUDAMEDFDA UDIs-Clean Multi Use Coping 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 Healing Cap (DSHIHC45) FDA UDIDental Implant Instrument / s-Clean Multi Use Coping FDA UDIs-Clean Multi Use Coping Healing Cap (DSHIHC55) FDA UDI
- Model / Reference
- DSHIHC45 EUDAMEDFDA UDIDSMUC5584S EUDAMEDFDA UDIDSMUCN4564S EUDAMEDFDA UDIDSMUC4544S EUDAMEDFDA UDIDSMUC6584S EUDAMEDFDA UDIDSHIHC55 EUDAMEDFDA UDIDSMUC5534S EUDAMEDFDA UDIDSMUC5524S EUDAMEDFDA UDIDSMUC5564S EUDAMEDFDA UDIDSMUCN4584S EUDAMEDFDA UDIDSMUC6524S EUDAMEDFDA UDIDSMUC4534S EUDAMEDFDA UDIDSMUCN4524 EUDAMEDFDA UDIDSMUCN4534 EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMEDDSMUCM4544S EUDAMEDDSMUC4584 EUDAMEDDSMUC4524 EUDAMEDDSMUC6544 EUDAMEDDSMUC5584 EUDAMEDDSMUCM4534S EUDAMEDDSMUCM5544S EUDAMEDDSMUCM4564S EUDAMEDDSMUC6564 EUDAMEDDSMUCM4584 EUDAMEDDSMUC5564 EUDAMEDDSMUCM4564 EUDAMEDDSMUCM5534 EUDAMEDDSMUC4534 EUDAMEDDSMUCM5534S EUDAMEDDSMUCM5544 EUDAMEDDSMUCM4524 EUDAMEDDSMUC5534 EUDAMEDDSMUC5544 EUDAMEDDSMUCM5564S EUDAMED
- Description
- s-Clean Multi Use Coping Healing Cap (DSHIHC45) FDA UDIDental Implant Instrument / s-Clean Multi Use Coping FDA UDIs-Clean Multi Use Coping Healing Cap (DSHIHC55) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806169154408 EUDAMEDFDA UDI08800053023337 EUDAMEDFDA UDI08800053081870 EUDAMEDFDA UDI08800053023269 EUDAMEDFDA UDI08800053023382 EUDAMEDFDA UDI08806169154415 EUDAMEDFDA UDI08800053023306 EUDAMEDFDA UDI08800053023290 EUDAMEDFDA UDI08800053023320 EUDAMEDFDA UDI08800053081887 EUDAMEDFDA UDI08800053023344 EUDAMEDFDA UDI08800053023252 EUDAMEDFDA UDI08800053081795 EUDAMEDFDA UDI08800053081801 EUDAMEDFDA UDI08800053092203 EUDAMED08800053023139 EUDAMED08800053023092 EUDAMED08800053023214 EUDAMED08800053023184 EUDAMED08800053092197 EUDAMED08800053092258 EUDAMED08800053092210 EUDAMED08800053023221 EUDAMED08800053092128 EUDAMED08800053023177 EUDAMED08800053092111 EUDAMED08800053092142 EUDAMED08800053023108 EUDAMED08800053092241 EUDAMED08800053092159 EUDAMED08800053092081 EUDAMED08800053023153 EUDAMED08800053023160 EUDAMED08800053092265 EUDAMED
- Basic UDI-DI
- 88061691DENTIS-I7L EUDAMED
- 510(k) Number
- K230126 FDA UDI
- FDA Product Code
- NHA FDA UDINDP 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 UDIClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI872.3980 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
No
FDA UDIFDA 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
s-Clean Multi Use Coping Healing Cap by Dentis Co. , Ltd — Class II — 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
Cleared under the same submission
K230126 also covers:
- SAVE Wide Cap — DENTIS CO. , LTD
- s-Clean Angled Abutment — DENTIS CO. , LTD
- s-Clean Angled Abutment — DENTIS CO. , LTD
- s-Clean Angled Abutment — DENTIS CO. , LTD
- s-Clean Angled Abutment — DENTIS CO. , LTD
- s-Clean Angled Abutment — DENTIS CO. , LTD
- s-Clean Angled Abutment — DENTIS CO. , LTD
- s-Clean Angled Abutment — DENTIS CO. , LTD
- s-Clean Angled Abutment — DENTIS CO. , LTD
- s-Clean Angled Abutment — DENTIS CO. , LTD
- s-Clean Angled Abutment — DENTIS CO. , LTD
- s-Clean Angled Abutment — DENTIS CO. , LTD
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dentis Co. , Ltd
Sources (48)
- FDA UDI 38f166b3-0105-4935-98e6-0c9676ff8e07 34 fields · synced Sep 30, 2026
- FDA UDI 0218d362-11cf-46a4-b015-b156b20d1415 33 fields · synced May 25, 2026
- FDA UDI d5636c78-5f16-445c-a3cf-4286f3e34891 33 fields · synced May 25, 2026
- FDA UDI d03a7491-2039-4f5f-a008-473994766936 33 fields · synced May 30, 2026
- FDA UDI abd0eb29-60c6-4218-aee8-a6e8031768e2 33 fields · synced May 30, 2026
- FDA UDI c7ee3d44-96b7-4160-a369-27595509b46b 34 fields · synced May 30, 2026
- FDA UDI f3f2b77e-09e4-4fd8-9e3d-99eaab5ce33b 33 fields · synced May 30, 2026
- FDA UDI b1d3a0d6-fb8d-483e-a3fc-b70b9a704f69 33 fields · synced May 30, 2026
- FDA UDI dd0ed1af-2f30-4830-8f4c-c0dd8a0d1c2f 33 fields · synced May 30, 2026
- FDA UDI 9a9e1176-5368-4340-9162-295020967cd2 33 fields · synced May 30, 2026
- FDA UDI e4f8cf9c-5136-49eb-982e-32678ece7aac 33 fields · synced May 30, 2026
- FDA UDI d90688bf-f375-4b9b-8570-dc18b2212e56 33 fields · synced May 30, 2026
- FDA UDI 1989a7b8-ff67-4812-bd7d-08f196638666 33 fields · synced May 30, 2026
- FDA UDI ce41036a-7cbd-407e-a28d-c8b4159c7822 33 fields · synced May 30, 2026
- EUDAMED a67f5fa1-1ea0-4d75-afe8-d92073289ede 61 fields · synced Jun 20, 2026
- EUDAMED b1388049-44a2-4b72-bf2c-8f5f519c649b 61 fields · synced Jul 8, 2026
- EUDAMED 95b7d2dc-450b-44ca-84cb-b6abb6e1f2b9 61 fields · synced Jul 9, 2026
- EUDAMED 916d2d83-fa31-4452-b25b-4964fdad86e1 61 fields · synced Jul 9, 2026
- EUDAMED 8393a315-32b8-4e7a-834c-139b77cb14ce 61 fields · synced Jul 9, 2026
- EUDAMED 85c7668b-8894-4704-8425-8e43c66475f6 61 fields · synced Jul 9, 2026
- EUDAMED 598d43fa-7c43-4434-aab5-fdaaacff12b1 61 fields · synced Jul 10, 2026
- EUDAMED e33ef239-1cf3-49f4-aa8b-8412a34df83a 61 fields · synced Jul 11, 2026
- EUDAMED 76765a1c-f776-4938-beed-2717fdd9b80c 61 fields · synced Jul 12, 2026
- EUDAMED 786678e1-9f9e-46ac-87a6-863d3b8b9336 61 fields · synced Jul 14, 2026
- EUDAMED d25a6ab4-3706-44a9-8ef7-0453bb247957 61 fields · synced Jul 15, 2026
- EUDAMED 3d94e213-e4c5-4fed-8eaa-566ec33c4186 61 fields · synced Jul 15, 2026
- EUDAMED 8391cd3d-236a-492b-9eb8-0ad83c9a95ae 61 fields · synced Jul 15, 2026
- EUDAMED 06da9baf-f451-4680-b18c-a4f1fc5753e2 61 fields · synced Jul 16, 2026
- EUDAMED 5c6146be-8e19-4b51-8a31-40c83f5463a5 61 fields · synced Jul 16, 2026
- EUDAMED 8733288b-b8bc-445c-aab3-6aeb2f8aca72 61 fields · synced Jul 17, 2026
- EUDAMED fad113d3-3c6b-4441-a05f-b287250147db 61 fields · synced Jul 17, 2026
- EUDAMED 575073b1-3d59-4b31-8112-92eb2d545246 61 fields · synced Jul 18, 2026
- EUDAMED 6730f7e5-1b4a-4e65-89f1-46110f6f7203 61 fields · synced Jul 18, 2026
- EUDAMED 0d541a78-3c5e-4fe4-bcac-f3230c6e7ff5 61 fields · synced Jul 19, 2026
- EUDAMED 765aad0f-34d1-4186-9867-d6b697b2f48f 61 fields · synced Jul 20, 2026
- EUDAMED 61bea9c1-e7c0-4289-ab80-f1a0f171d9c6 61 fields · synced Jul 21, 2026
- EUDAMED 9cc3273d-9a28-4d21-8196-b7f6ac49a50e 61 fields · synced Jul 21, 2026
- EUDAMED 6765d545-7a01-47e2-bd68-87dda92f108d 61 fields · synced Jul 22, 2026
- EUDAMED bfe94fb3-bc5e-41e5-b832-491b778446ad 61 fields · synced Jul 23, 2026
- EUDAMED 5ce3b854-9b84-42c9-ad32-da8a01c21201 61 fields · synced Jul 23, 2026
- EUDAMED 52c72d85-ac0d-4790-8f4a-e36cc32af623 61 fields · synced Jul 25, 2026
- EUDAMED 3797b50a-0106-48f1-90eb-7f394b737a43 61 fields · synced Jul 25, 2026
- EUDAMED bcd5c02c-2994-4dca-a1e5-0dce97a57f6e 61 fields · synced Jul 26, 2026
- EUDAMED 20876470-87f5-4ded-ad04-1d600c59b4fc 61 fields · synced Jul 27, 2026
- EUDAMED 65fc450a-57ee-4dae-bbc5-7d64bcf6918e 61 fields · synced Jul 28, 2026
- EUDAMED e8ec1a21-7cdd-4506-a852-269262c59f98 61 fields · synced Jul 30, 2026
- EUDAMED afab18f7-cbdf-4582-af4d-8aaafb3d9e9d 61 fields · synced Jul 30, 2026
- EUDAMED fc9abc61-48c6-4ee0-ac5c-daa593ad567b 61 fields · synced Jul 31, 2026