Healing Abutment
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Healing Abutment EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Dental Healing Abutment EUDAMED
- Model / Reference
- HA4506R EUDAMEDFDA UDIHA5505R EUDAMEDFDA UDIHAA6506R EUDAMEDHAA4002R EUDAMEDHA6080 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809917603586 EUDAMEDFDA UDI08809917603661 EUDAMEDFDA UDI08809917602961 EUDAMED08809917602657 EUDAMED08800275825757 FDA UDI
- Basic UDI-DI
- 88000557HAAP 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
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 |
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Manufacturer
- Manufacturer
- ARUM DENTISTRY Co., Ltd.
Sources (7)
- FDA UDI cab7415c-e83d-43dc-bdcb-72e11861ace1 33 fields · synced Jul 29, 2026
- FDA UDI ed975fe4-c8b9-4df3-9c85-4e080ad6b520 33 fields · synced May 25, 2026
- FDA UDI 74e39e27-fadb-47ec-8d50-fb1822cbf2f0 33 fields · synced May 30, 2026
- EUDAMED 40cd76c2-277c-49ac-99bb-78a842027243 61 fields · synced Jul 12, 2026
- EUDAMED 65960b1e-949f-4423-ba20-bdb631c5852e 61 fields · synced Jul 17, 2026
- EUDAMED 379d1b7b-9fa5-4e6e-aace-33fa95402c5c 61 fields · synced Jul 20, 2026
- EUDAMED 02083ff5-a84c-496e-9165-f8d05884b1f0 61 fields · synced Jul 29, 2026