Scan Healing Abutment
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Scan Healing Abutment EUDAMEDFDA UDIScan Healing Abutment Screw EUDAMEDFDA UDIAbutment Screw EUDAMED
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Dental Healing Abutment EUDAMEDAbutment and Abutment screw EUDAMED
- Model / Reference
- HAS5507R EUDAMEDFDA UDIHAS6511R EUDAMEDFDA UDIHAS7503RP EUDAMEDFDA UDIHAS6505RP EUDAMEDFDA UDIHAS4505R EUDAMEDFDA UDIHAS6503RP EUDAMEDFDA UDIHAS4511R EUDAMEDFDA UDIHAS7509RP EUDAMEDFDA UDIHAS4503RP EUDAMEDFDA UDIHAS5507RP EUDAMEDFDA UDIHAS4511RP EUDAMEDFDA UDIHAS7511R EUDAMEDFDA UDIHAS7509R EUDAMEDFDA UDIHAS5505R EUDAMEDFDA UDIHAS5503RP EUDAMEDFDA UDIHAS6505R EUDAMEDFDA UDIHAS-S18R EUDAMEDFDA UDIHAS5509RP EUDAMEDFDA UDIHAS5505RP EUDAMEDFDA UDIHAS6509RP EUDAMEDFDA UDIHAS4509R EUDAMEDFDA UDIHAS6503R EUDAMEDFDA UDIHAS5511R EUDAMEDFDA UDIHAS6507R EUDAMEDFDA UDIHAS7505R EUDAMEDFDA UDIHAS7507R EUDAMEDFDA UDIHAS6509R EUDAMEDFDA UDIHAS5503R EUDAMEDFDA UDILSTO023 EUDAMEDLSHE023 EUDAMEDCSTO031 EUDAMEDCSHE502 EUDAMEDCSHE060 EUDAMEDCSHE048 EUDAMEDCSTO505 EUDAMEDCSHE094 EUDAMEDLSHE067 EUDAMEDCSHE021 EUDAMEDLSHE311 EUDAMEDLSHE015 EUDAMEDCSHE023 EUDAMEDCSHE406 EUDAMEDLSTO026 EUDAMEDLSHE071 EUDAMEDHAS-S16R FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809917606174 EUDAMEDFDA UDI08809917606242 EUDAMEDFDA UDI08809917605856 EUDAMEDFDA UDI08809917605818 EUDAMEDFDA UDI08809917606112 EUDAMEDFDA UDI08809917605801 EUDAMEDFDA UDI08809917606143 EUDAMEDFDA UDI08809917605887 EUDAMEDFDA UDI08809917605702 EUDAMEDFDA UDI08809917605771 EUDAMEDFDA UDI08809917605740 EUDAMEDFDA UDI08809917606297 EUDAMEDFDA UDI08809917606280 EUDAMEDFDA UDI08809917606167 EUDAMEDFDA UDI08809917605757 EUDAMEDFDA UDI08809917606211 EUDAMEDFDA UDI08809917605993 EUDAMEDFDA UDI08809917605788 EUDAMEDFDA UDI08809917605764 EUDAMEDFDA UDI08809917605832 EUDAMEDFDA UDI08809917606136 EUDAMEDFDA UDI08809917606204 EUDAMEDFDA UDI08809917606198 EUDAMEDFDA UDI08809917606228 EUDAMEDFDA UDI08809917606266 EUDAMEDFDA UDI08809917606273 EUDAMEDFDA UDI08809917606235 EUDAMEDFDA UDI08809917606150 EUDAMEDFDA UDI08800055749440 EUDAMED08800055722566 EUDAMED08800055746708 EUDAMED08800055721187 EUDAMED08800055718231 EUDAMED08800055718118 EUDAMED08800055721279 EUDAMED08800055746432 EUDAMED08800055749037 EUDAMED08800055717845 EUDAMED08800055750491 EUDAMED08800055722481 EUDAMED08800055717869 EUDAMED08800055720753 EUDAMED08800055749471 EUDAMED08800055749075 EUDAMED08800055793313 FDA UDI
- Basic UDI-DI
- 88000557HAAP EUDAMED88000557CADCAMAY EUDAMED
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Dental implant suprastructure, temporary, preformed, single-use
Scan Healing Abutment by ARUM DENTISTRY 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
K240091 also covers:
- Angled Abutment Mini — ARUM DENTISTRY Co., Ltd.
- Angled Abutment Mini — ARUM DENTISTRY Co., Ltd.
- Angled Abutment Mini — ARUM DENTISTRY Co., Ltd.
- Angled Abutment Mini — ARUM DENTISTRY Co., Ltd.
- Angled Abutment Mini — ARUM DENTISTRY Co., Ltd.
- Angled Abutment Mini — ARUM DENTISTRY Co., Ltd.
- Cemented Abutment Mini — ARUM DENTISTRY Co., Ltd.
- Cemented Abutment Mini — ARUM DENTISTRY Co., Ltd.
- Cemented Abutment Mini — ARUM DENTISTRY Co., Ltd.
- Cemented Abutment Mini — ARUM DENTISTRY Co., Ltd.
- Cemented Abutment Mini — ARUM DENTISTRY Co., Ltd.
- Cemented Abutment Mini — ARUM DENTISTRY Co., Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- ARUM DENTISTRY Co., Ltd.
Sources (73)
- FDA UDI 2a032d3e-3060-4434-b39d-f868d4c6cacc 33 fields · synced Sep 18, 2026
- FDA UDI 576c4aa9-14b5-467c-8fd8-9886bb203806 33 fields · synced May 24, 2026
- FDA UDI d1008730-4af3-4e8a-b1f1-de5cf6fca061 33 fields · synced May 24, 2026
- FDA UDI 797b015d-505a-4b93-8fe2-ca4a06ff3605 33 fields · synced May 24, 2026
- FDA UDI 4184e5af-89ce-412a-8602-0e1cdbb77e3d 33 fields · synced May 25, 2026
- FDA UDI d6f422df-d642-4771-8838-407984aeac81 33 fields · synced May 25, 2026
- FDA UDI c90e2972-03b2-4c60-94d6-d61bc2e11f75 33 fields · synced May 29, 2026
- FDA UDI 69c223eb-11c6-4ba6-9c2a-2faaf7501f5f 33 fields · synced May 29, 2026
- FDA UDI 7e122ee9-7c09-4ba7-9080-437c2606a753 33 fields · synced May 29, 2026
- FDA UDI 6cd7a85a-a592-4dcf-9a14-06346f6696a1 33 fields · synced May 29, 2026
- FDA UDI b468c979-cb69-4ae5-9619-1e696c9a4b58 33 fields · synced May 30, 2026
- FDA UDI 10bf33ea-34e0-4379-b4ae-cab8a0ee63a4 33 fields · synced May 30, 2026
- FDA UDI a01504bc-0b13-47a2-aa5f-52060a5e87b2 33 fields · synced May 30, 2026
- FDA UDI de40d9e6-2622-4d71-a072-65b5a946c082 33 fields · synced May 30, 2026
- FDA UDI 60cb2fd8-e4a1-4dec-9abb-581babab576a 33 fields · synced May 30, 2026
- FDA UDI 62286ae9-88c1-43b1-b122-2cbe5b9934c6 33 fields · synced May 30, 2026
- FDA UDI 86dd9027-a077-4998-8b44-bafd181fca11 33 fields · synced May 30, 2026
- FDA UDI ea3c99ef-07c1-4448-924d-bc8c3ad511e3 33 fields · synced May 30, 2026
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- FDA UDI 5df29a6d-e0a2-4ff9-aa83-36623a61aa52 33 fields · synced May 30, 2026
- FDA UDI 4757ec5d-71a1-41c1-94aa-dc42a129aa2b 33 fields · synced May 30, 2026
- FDA UDI b07c1d90-6947-41a3-b1ef-086cb13f4936 33 fields · synced May 30, 2026
- FDA UDI 57f2e317-7e1c-4e64-8764-9b12d77fca83 33 fields · synced May 30, 2026
- FDA UDI 9809973c-feb9-4258-b3b1-1ab66b012f89 33 fields · synced May 30, 2026
- FDA UDI aaec3a07-af90-4268-820f-0518ae57f0bd 33 fields · synced May 30, 2026
- FDA UDI 64ca4ee5-8300-45b2-a69f-a7e095a96926 33 fields · synced May 30, 2026
- FDA UDI 40de126b-0707-4f8d-b070-4b224b0e7f99 33 fields · synced May 30, 2026
- FDA UDI 62ae818f-98f9-4d0d-9330-6c1b1c5cb0ba 33 fields · synced May 30, 2026
- EUDAMED 84ce5508-a9b4-487f-8a17-3b90bc2d14c6 61 fields · synced Jul 9, 2026
- EUDAMED 14c94760-64b7-420a-a92a-5852f19d7bb7 61 fields · synced Jul 9, 2026
- EUDAMED 564d105d-3d00-45af-aef8-5feff0f08209 61 fields · synced Jul 9, 2026
- EUDAMED 87c0a1c4-973c-4e93-831a-ff8fbe3fef72 61 fields · synced Jul 10, 2026
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- EUDAMED 2266d453-5264-4816-8109-ce00b2667144 61 fields · synced Jul 10, 2026
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- EUDAMED 6dad35b3-b0b1-49b7-b35b-c50b335b9202 61 fields · synced Jul 11, 2026
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- EUDAMED 79e604ff-6454-4923-bfd6-0b11a1401730 61 fields · synced Jul 13, 2026
- EUDAMED f246f2c7-f0bd-4227-a7c5-11c6531480cb 61 fields · synced Jul 13, 2026
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- EUDAMED 0bab4115-15cb-47d3-87a5-598f0c1c658a 61 fields · synced Jul 14, 2026
- EUDAMED a24983ca-56e9-4797-9256-f2c2a8717088 61 fields · synced Jul 14, 2026
- EUDAMED d4c2caa5-b864-482f-b2f1-addd432830b4 61 fields · synced Jul 15, 2026
- EUDAMED 65c6497c-e87d-4ef7-9e8a-9ace26d2d832 61 fields · synced Jul 15, 2026
- EUDAMED 7bef0b62-c29a-45c7-9c60-52cc94ef4963 61 fields · synced Jul 16, 2026
- EUDAMED 78089f14-989d-4063-9e16-404418c7400b 61 fields · synced Jul 16, 2026
- EUDAMED 0ffcf43f-8024-4f47-8d03-dcbb50a49cca 61 fields · synced Jul 16, 2026
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- EUDAMED 26f9b3d0-5760-4e1d-a0f7-ca67dd83427f 61 fields · synced Jul 22, 2026
- EUDAMED afabd77b-281d-4ce0-919b-a6eaa0112c78 61 fields · synced Jul 23, 2026
- EUDAMED 4e00b344-20b5-42da-b5e1-6ffa58a99f63 61 fields · synced Jul 24, 2026
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- EUDAMED d6720ad5-29de-4b67-809b-38bbdea53335 61 fields · synced Jul 26, 2026
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- EUDAMED 2f5f30c4-bec8-4261-a1c3-ee44087689c4 61 fields · synced Jul 27, 2026
- EUDAMED 9d753665-2091-4165-991f-a164f39261a1 61 fields · synced Jul 28, 2026
- EUDAMED 6ffb34ea-cc6a-4142-a630-de19a94ac60e 61 fields · synced Jul 30, 2026
- EUDAMED 16a591ef-5247-421b-8fe2-ca8547b5e299 61 fields · synced Jul 30, 2026
- EUDAMED 6538a820-4769-4aad-8833-52699c75f860 61 fields · synced Jul 30, 2026
- EUDAMED 42e02ff3-0f78-47bc-993b-322df8d1ac35 61 fields · synced Jul 30, 2026
- EUDAMED 5097d256-fa1b-43de-b4ce-3e2deed3dbe8 61 fields · synced Aug 1, 2026