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IS Encoded Healing Abutment Pin
EUDAMEDFDA UDIClass I (EU MDR)
Ref ISEHAPRef ISH602Ref ISH702Ref ISH3003Ref ISH705Ref ISH3005Ref ISH804Ref ISUH4504Ref ISUH4506Ref ISH406Ref ISH703Ref ISUH4003Ref ISH507Ref ISH706Ref ISH607Ref ISH405Ref ISH805Ref ISH806Ref ISUH4006Ref ISH603Ref ISH3803Ref ISUH4503Ref ISH707Ref ISH402Ref ISH606Ref ISH807
Identity
- Trade Name
- IS Encoded Healing Abutment Pin EUDAMEDIS healing abutment EUDAMEDNeobiotech Implant System FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Device Name
- Dental Surgical Instrument EUDAMEDØ6.8*6.8mm FDA UDIØ4.0*3mm FDA UDIØ5.5*7.8mm FDA UDIØ6.8*5.8mm FDA UDIØ6.0*3.8mm FDA UDIØ6.8*3.8mm FDA UDIØ6.8*7.8mm FDA UDIØ4.5*3mm FDA UDIØ4.8*6.8mm FDA UDIØ6.0*6.8mm FDA UDIØ3.0*5.0mm FDA UDIØ6.0*2.8mm FDA UDIØ6.0*7.8mm FDA UDIØ3.0, L:4.9mm FDA UDIØ3.8*3.0mm FDA UDIØ4.8*5.8mm FDA UDIØ3.0*3.0mm FDA UDIØ4.8*2mm FDA UDIØ8.0*4.8mm FDA UDIØ4.5*4mm FDA UDIØ4.0*6mm FDA UDIØ6.8*2.8mm FDA UDI
- Model / Reference
- ISEHAP EUDAMEDFDA UDIISH706 EUDAMEDFDA UDIISUH4003 EUDAMEDFDA UDIISH507 EUDAMEDFDA UDIISH705 EUDAMEDFDA UDIISH603 EUDAMEDFDA UDIISH703 EUDAMEDFDA UDIISH707 EUDAMEDFDA UDIISUH4503 EUDAMEDFDA UDIISH406 EUDAMEDFDA UDIISH606 EUDAMEDFDA UDIISH3005 EUDAMEDFDA UDIISH602 EUDAMEDFDA UDIISH607 EUDAMEDFDA UDIISH3803 EUDAMEDFDA UDIISH405 EUDAMEDFDA UDIISH3003 EUDAMEDFDA UDIISH402 EUDAMEDFDA UDIISH804 EUDAMEDFDA UDIISUH4504 EUDAMEDFDA UDIISUH4006 EUDAMEDFDA UDIISH702 EUDAMEDFDA UDIISUH4506 EUDAMEDISH805 EUDAMEDISH806 EUDAMEDISH807 EUDAMED
- Description
- Ø6.8*6.8mm FDA UDIØ4.0*3mm FDA UDIØ5.5*7.8mm FDA UDIØ6.8*5.8mm FDA UDIØ6.0*3.8mm FDA UDIØ6.8*3.8mm FDA UDIØ6.8*7.8mm FDA UDIØ4.5*3mm FDA UDIØ4.8*6.8mm FDA UDIØ6.0*6.8mm FDA UDIØ3.0*5.0mm FDA UDIØ6.0*2.8mm FDA UDIØ6.0*7.8mm FDA UDIØ3.0, L:4.9mm FDA UDIØ3.8*3.0mm FDA UDIØ4.8*5.8mm FDA UDIØ3.0*3.0mm FDA UDIØ4.8*2mm FDA UDIØ8.0*4.8mm FDA UDIØ4.5*4mm FDA UDIØ4.0*6mm FDA UDIØ6.8*2.8mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809815654956 EUDAMEDFDA UDI08809407154376 EUDAMEDFDA UDI08809407155236 EUDAMEDFDA UDI08809486290255 EUDAMEDFDA UDI08809407154369 EUDAMEDFDA UDI08809407154284 EUDAMEDFDA UDI08809407154345 EUDAMEDFDA UDI08809407154383 EUDAMEDFDA UDI08809407155281 EUDAMEDFDA UDI08809486290200 EUDAMEDFDA UDI08809407154314 EUDAMEDFDA UDI08809486296752 EUDAMEDFDA UDI08809407154277 EUDAMEDFDA UDI08809407154321 EUDAMEDFDA UDI08809486296769 EUDAMEDFDA UDI08809486290347 EUDAMEDFDA UDI08809486296745 EUDAMEDFDA UDI08809486290163 EUDAMEDFDA UDI08809407154413 EUDAMEDFDA UDI08809407155298 EUDAMEDFDA UDI08809407155267 EUDAMEDFDA UDI08809407154338 EUDAMEDFDA UDI08809407155311 EUDAMED08809407154420 EUDAMED08809407154437 EUDAMED08809407154444 EUDAMED
- Basic UDI-DI
- 880927676NBRSIRSCL1S03FT EUDAMEDB-08809407154277 EUDAMEDB-08809407154338 EUDAMEDB-08809486296745 EUDAMEDB-08809407154369 EUDAMEDB-08809486296752 EUDAMEDB-08809407154413 EUDAMEDB-08809407155298 EUDAMEDB-08809407155311 EUDAMEDB-08809486290200 EUDAMEDB-08809407154345 EUDAMEDB-08809407155236 EUDAMEDB-08809486290255 EUDAMEDB-08809407154376 EUDAMEDB-08809407154321 EUDAMEDB-08809486290347 EUDAMEDB-08809407154420 EUDAMEDB-08809407154437 EUDAMEDB-08809407155267 EUDAMEDB-08809407154284 EUDAMEDB-08809486296769 EUDAMEDB-08809407155281 EUDAMEDB-08809407154383 EUDAMEDB-08809486290163 EUDAMEDB-08809407154314 EUDAMEDB-08809407154444 EUDAMED
- FDA Product Code
- NHA FDA UDINDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMEDP01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental implant system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI872.3980 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDIEUDAMEDFDA UDI
Single Use
Yes
FDA UDIFDA UDI
Implantable
No
EUDAMEDEUDAMEDFDA UDI
Reusable
Yes
EUDAMEDEUDAMED
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDIFDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
IS Encoded Healing Abutment Pin by Neobiotech Co., Ltd. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 880927676NBRSIRSCL1S03FT | Class I | Active |
| EUDAMED | European Union | CE/MDR | 880927676NBRSIRSCL1S03FT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Neobiotech Co., Ltd.
- EUDAMED SRN
- KR-MF-000016946
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (48)
- EUDAMED a90408dc-9b67-46fc-a91b-27294b2cf83b 61 fields · synced Aug 4, 2026
- FDA UDI dc11f8b2-0058-4864-b7de-d8d0af5b8547 34 fields · synced May 29, 2026
- FDA UDI d8a94140-e1fe-4e5f-9edf-952b29519063 34 fields · synced May 29, 2026
- FDA UDI 4bc21dd7-b2e9-4ded-82a3-13b5dac637f3 34 fields · synced May 29, 2026
- FDA UDI 3b99c2d6-a089-4f6a-aa67-46e818b02eb2 34 fields · synced May 29, 2026
- FDA UDI 39f2c526-1e99-40c6-9b39-ce3a00aa3fd5 34 fields · synced May 29, 2026
- FDA UDI 15101db5-182a-4471-a6b4-6e38861f7ac7 34 fields · synced May 29, 2026
- FDA UDI ffb26007-c78d-4204-a9a8-ebf828f88fd2 34 fields · synced May 30, 2026
- FDA UDI d0ac10d6-179c-4c9e-9346-715fdf4b03dc 34 fields · synced May 30, 2026
- FDA UDI 0059e721-4344-4ba3-86c2-59d05a854850 34 fields · synced May 30, 2026
- FDA UDI fafcfebd-0390-4d69-9bae-b8b011f6983d 34 fields · synced May 30, 2026
- FDA UDI 66257103-a8bf-48e1-90e6-81534930871b 34 fields · synced May 30, 2026
- FDA UDI cc54c12e-00d3-49c5-a740-033682ec67ad 34 fields · synced May 30, 2026
- FDA UDI d7789f24-b8b5-4c5f-8e56-be8c4197d92c 34 fields · synced May 30, 2026
- FDA UDI 5244fd05-4664-47ec-a616-014c65f7d660 33 fields · synced May 30, 2026
- FDA UDI 2e1a403d-bea5-4ea6-a2d4-9b738091fb16 34 fields · synced May 30, 2026
- FDA UDI 77283351-023f-4d88-9535-9119e632d4ff 34 fields · synced May 30, 2026
- FDA UDI 91504837-16b9-4e36-82b1-6a3f0614344e 34 fields · synced May 30, 2026
- FDA UDI 58d06e22-f155-4ed1-8bca-112aea2fdc06 34 fields · synced May 30, 2026
- FDA UDI 049d43ac-6bf8-49e3-b596-eec0fb4d8b94 34 fields · synced May 30, 2026
- FDA UDI fb0df5fd-e523-4963-8f82-865f0857a0a8 34 fields · synced May 30, 2026
- FDA UDI 87649f0e-3768-416e-a0f5-815a590d4f77 34 fields · synced May 30, 2026
- FDA UDI bd962aaf-c046-4e74-8e38-1318e75117ff 34 fields · synced May 30, 2026
- EUDAMED 305bb037-e192-4f0f-b645-1a9aa1481a0a 61 fields · synced Jun 20, 2026
- EUDAMED e3c0e248-3433-43c5-8d48-463b09cfcaad 61 fields · synced Jul 9, 2026
- EUDAMED f2d5cb96-faa5-46fa-9823-6f052cf63e3d 61 fields · synced Jul 9, 2026
- EUDAMED 20cf8364-6db9-4576-8648-2bc2f3ea6b86 61 fields · synced Jul 9, 2026
- EUDAMED 3fd0e006-396d-489a-aa96-73487317ff92 61 fields · synced Jul 10, 2026
- EUDAMED 9bcfa466-3d79-4125-b130-635d526726e2 61 fields · synced Jul 10, 2026
- EUDAMED a6de8a15-23ab-414f-90eb-eeec745fa2d6 61 fields · synced Jul 10, 2026
- EUDAMED 8913400f-db92-42bc-9663-08e796bf7fb2 61 fields · synced Jul 11, 2026
- EUDAMED f94cd070-612a-4d13-9be8-663cbe6089f0 61 fields · synced Jul 11, 2026
- EUDAMED 893d82f3-3f61-441d-b221-cc2f34649d2b 61 fields · synced Jul 12, 2026
- EUDAMED f85b6095-513c-49c7-93ee-f6e691773cc8 61 fields · synced Jul 12, 2026
- EUDAMED 4fcfa0a2-8b03-4f0e-afd6-bee9066ac5ec 61 fields · synced Jul 13, 2026
- EUDAMED 5768db6d-87d3-4e55-8329-7d46e6853f12 61 fields · synced Jul 14, 2026
- EUDAMED 8cf5df5a-0a7d-41f4-affc-a9f449232596 61 fields · synced Jul 14, 2026
- EUDAMED 5e921210-bd93-4ab4-9c0d-fc49313e5e6b 61 fields · synced Jul 15, 2026
- EUDAMED 6914a717-8a41-4afb-905a-c805c1c4f93b 61 fields · synced Jul 17, 2026
- EUDAMED 08e7f076-5b3a-4da5-bfa6-192753e47d2d 61 fields · synced Jul 18, 2026
- EUDAMED c1e62b86-a2f6-490a-825f-b3e0a51136c1 61 fields · synced Jul 19, 2026
- EUDAMED dd6f0f0b-b4cd-4a0b-8c3d-5e467441ee48 61 fields · synced Jul 19, 2026
- EUDAMED 5cc0788a-6866-47a3-85ae-b51111dec1f2 61 fields · synced Jul 20, 2026
- EUDAMED 38dce09e-2d94-40fa-90d1-e954e849b8bd 61 fields · synced Jul 21, 2026
- EUDAMED 38928688-186a-4f5d-aa16-d4f0e9546875 61 fields · synced Jul 25, 2026
- EUDAMED c278b7c5-db8f-481e-8046-84aeeab4006a 61 fields · synced Jul 31, 2026
- EUDAMED a2c089f9-f12c-4838-9f95-610a516987ea 61 fields · synced Aug 1, 2026
- EUDAMED fbcf7f06-afba-4e98-9aa6-6fb6f96ee580 61 fields · synced Aug 4, 2026