Healing Abutment
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- HEALING CAP HE Ø4.1XØ4.1X4MM EUDAMEDHealing Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- HEALING CAP EUDAMEDHEALING CAP EXT HEX Ø 4,1 X 4,1 X 4MM FDA UDI
- Model / Reference
- CI 4104 EUDAMEDFDA UDISTERILE COMPONENTS EUDAMED
- Description
- HEALING CAP EXT HEX Ø 4,1 X 4,1 X 4MM FDA UDI
Identifiers
- Catalog Number
- CI 4104 FDA UDI
- Primary DI / UDI-DI
- 07899995205650 EUDAMEDFDA UDI
- Basic UDI-DI
- 999520000057KB EUDAMED
- 510(k) Number
- K170398 FDA UDI
- 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 IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
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
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Dental implant suprastructure, temporary, preformed, single-use
Healing Abutment by S.I.N. - Sistema DE Implante Nacional S.A. — 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
K170398 also covers:
- Cemented Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- Cemented Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- Conic Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- Conic Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- Conic Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- Cover Screw — S.I.N. - Sistema DE Implante Nacional S.A.
- Healing Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- Healing Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- Healing Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- Healing Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- Healing Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- Healing Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
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
- S.I.N. - Sistema DE Implante Nacional S.A.
Sources (2)
- FDA UDI 9253ea9c-307b-48e3-83ad-d9ff5260ab0c 35 fields · synced Jun 14, 2026
- EUDAMED 97a9fe00-1d6a-4551-8906-c3f1552772ab 61 fields · synced Jun 11, 2026