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NB II Fixture
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref NB26507SPRef NB26011SPRef NB26510SPRef NB25007SPRef NB24010SSRef NB26010SPRef NB25510SPRef NB26013SSRef NB25010SPRef NB25511SPRef NB24011SPRef NB24507SPRef NB24013SPRef NB25011SPRef NB24011SSRef NB24008SPRef NB26507SSRef NB25011SSRef NB26508SPRef NB26511SSRef NB24010SPRef NB25508SSRef NB25510SSRef NB24508SSRef NB24510SPRef NB25513SPRef NB25010SSRef NB24511SPRef NB24511SSRef NB25007SSRef NB26513SSRef NB24008SSRef NB24508SPRef NB26508SSRef NB25507SPRef NB26511SPRef NB25008SSRef NB25511SS
Identity
- Trade Name
- NB II Fixture EUDAMEDFDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDIBlade endosteal dental implant, two-piece FDA UDI
- Device Name
- Dental Implant Fixture EUDAMED
- Model / Reference
- NB24508SS EUDAMEDFDA UDINB24508SP EUDAMEDFDA UDINB24008SS EUDAMEDFDA UDINB25507SP EUDAMEDFDA UDINB26511SP EUDAMEDFDA UDINB25007SS EUDAMEDFDA UDINB26513SS EUDAMEDFDA UDINB26013SS EUDAMEDFDA UDINB26507SS EUDAMEDFDA UDINB24008SP EUDAMEDFDA UDINB25010SP EUDAMEDFDA UDINB25510SS EUDAMEDFDA UDINB26508SP EUDAMEDFDA UDINB26511SS EUDAMEDFDA UDINB25008SS EUDAMEDFDA UDINB24010SS EUDAMEDFDA UDINB26507SP EUDAMEDFDA UDINB26508SS EUDAMEDFDA UDINB25508SS EUDAMEDFDA UDINB25511SS EUDAMEDFDA UDINB24011SP EUDAMEDFDA UDINB24511SS EUDAMEDFDA UDINB25011SP EUDAMEDFDA UDINB25510SP EUDAMEDFDA UDINB24013SP EUDAMEDFDA UDINB26010SP EUDAMEDFDA UDINB25011SS EUDAMEDFDA UDINB24511SP EUDAMEDFDA UDINB25511SP EUDAMEDFDA UDINB25010SS EUDAMEDFDA UDINB25007SP EUDAMEDFDA UDINB24507SP EUDAMEDFDA UDINB24011SS EUDAMEDFDA UDINB26510SP EUDAMEDFDA UDINB25513SP EUDAMEDFDA UDINB24510SP EUDAMEDFDA UDINB26011SP EUDAMEDFDA UDINB24010SP EUDAMEDFDA UDINB24507SS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809917605368 EUDAMEDFDA UDI08800055777719 EUDAMEDFDA UDI08809917605313 EUDAMEDFDA UDI08800055777801 EUDAMEDFDA UDI08800055777931 EUDAMEDFDA UDI08809917605405 EUDAMEDFDA UDI08809917605597 EUDAMEDFDA UDI08809917605542 EUDAMEDFDA UDI08809917605559 EUDAMEDFDA UDI08800055777665 EUDAMEDFDA UDI08800055777771 EUDAMEDFDA UDI08809917605474 EUDAMEDFDA UDI08800055777917 EUDAMEDFDA UDI08809917605580 EUDAMEDFDA UDI08809917605412 EUDAMEDFDA UDI08809917605320 EUDAMEDFDA UDI08800055777900 EUDAMEDFDA UDI08809917605566 EUDAMEDFDA UDI08809917605467 EUDAMEDFDA UDI08809917605481 EUDAMEDFDA UDI08800055777689 EUDAMEDFDA UDI08809917605382 EUDAMEDFDA UDI08800055777788 EUDAMEDFDA UDI08800055777825 EUDAMEDFDA UDI08800055777696 EUDAMEDFDA UDI08800055777870 EUDAMEDFDA UDI08809917605436 EUDAMEDFDA UDI08800055777733 EUDAMEDFDA UDI08800055777832 EUDAMEDFDA UDI08809917605429 EUDAMEDFDA UDI08800055777757 EUDAMEDFDA UDI08800055777702 EUDAMEDFDA UDI08809917605337 EUDAMEDFDA UDI08800055777924 EUDAMEDFDA UDI08800055777849 EUDAMEDFDA UDI08800055777726 EUDAMEDFDA UDI08800055777887 EUDAMEDFDA UDI08800055777672 EUDAMEDFDA UDI08809917605351 FDA UDI
- Basic UDI-DI
- 88000557FIXXG EUDAMED
- 510(k) Number
- K230725 FDA UDI
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDIBlade endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
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 UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Screw endosteal dental implant, two-piece
NB II Fixture by ARUM DENTISTRY Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Screw endosteal dental implant, two-piece.
- ET III NH Ultra-Wide Fixture No-Mount — HIOSSEN INC. · Class II
- SNUCONE BONE LEVEL IMPLANT SYSTEM — SNUCONE Co., LTD. · Class II
- LW Solid Abutment — Ossvis Co., Ltd. · Class II
- LW Vis Abutment — Ossvis Co., Ltd. · Class II
- s-Clean TiN Half Coating Angled Abutment — DENTIS CO. , LTD · Class II
- ET II Fixture SA Mini No-Mounted — HIOSSEN INC. · Class II
- LW Vis Abutment — Ossvis Co., Ltd. · Class II
- PRAMA RF WHITE IMPLANT ZIRTI — SWEDEN & MARTINA INC · Class II
Cleared under the same submission
K230725 also covers:
- NB II Fixture — ARUM DENTISTRY Co., Ltd.
- NB II Fixture — ARUM DENTISTRY Co., Ltd.
- NB II Fixture — ARUM DENTISTRY Co., Ltd.
- NB II Fixture — ARUM DENTISTRY Co., Ltd.
- NB II Fixture — ARUM DENTISTRY Co., Ltd.
- NB II Fixture — ARUM DENTISTRY Co., Ltd.
- NB II Fixture — ARUM DENTISTRY Co., Ltd.
- NB II Fixture — ARUM DENTISTRY Co., Ltd.
- NB II Fixture — ARUM DENTISTRY Co., Ltd.
- NB II Fixture — ARUM DENTISTRY Co., Ltd.
- NB II Fixture — ARUM DENTISTRY Co., Ltd.
- NB II Fixture — ARUM DENTISTRY 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
- ARUM DENTISTRY Co., Ltd.
Sources (77)
- FDA UDI c378546e-8257-49a0-b3b2-95c6c304011f 33 fields · synced Sep 17, 2026
- FDA UDI 604c90c1-2d79-4554-85e1-2d62c211b501 33 fields · synced May 24, 2026
- FDA UDI 9193c91b-d590-41fb-9582-7268a6454fbf 33 fields · synced May 24, 2026
- FDA UDI 09856fea-a582-43ad-8664-1d4c4349d096 33 fields · synced May 24, 2026
- FDA UDI 67b7b2a7-6fed-4b9c-a280-d0a5b9e2b8ec 33 fields · synced May 25, 2026
- FDA UDI 56907bf8-fae3-402c-b2d4-94eb079a9014 33 fields · synced May 25, 2026
- FDA UDI 5f89cdcb-d05e-430b-b971-c70d5cff2af0 33 fields · synced May 27, 2026
- FDA UDI 4239ccf0-726b-4043-b404-37cab955947d 33 fields · synced May 29, 2026
- FDA UDI d953b128-0b18-433e-9343-fff5d6c2fb8e 33 fields · synced May 29, 2026
- FDA UDI d6d83d22-92e6-4413-bf32-f2f7e0d658f7 33 fields · synced May 30, 2026
- FDA UDI 84e9d8f0-2f07-4a1c-bd56-a98913f75a8c 33 fields · synced May 30, 2026
- FDA UDI f6359c15-aa56-4e0e-b9ba-ca15e1b77c13 33 fields · synced May 30, 2026
- FDA UDI 8a1b6e91-0f01-4864-9110-723ccc7e6957 33 fields · synced May 30, 2026
- FDA UDI aae78df7-9cbc-484b-9e8b-ea5e874b799d 33 fields · synced May 30, 2026
- FDA UDI 852a1aa3-3dd2-4b82-b44a-82482a8fdc7a 33 fields · synced May 30, 2026
- FDA UDI 7dadda07-c08b-4304-a755-8a91093893dc 33 fields · synced May 30, 2026
- FDA UDI 5b19fc6c-8dc0-45ef-aabb-f6e13b965911 33 fields · synced May 30, 2026
- FDA UDI 832b372a-539a-4139-b38d-4e479c6e7293 33 fields · synced May 30, 2026
- FDA UDI afe13c92-c5a6-4d68-9549-28482a788bbe 33 fields · synced May 30, 2026
- FDA UDI be6984f7-4b88-47ca-a36d-40b0798f3094 33 fields · synced May 30, 2026
- FDA UDI c4a8b2c5-9243-472c-8379-4d924147f37b 33 fields · synced May 30, 2026
- FDA UDI a4208de1-a9b0-477e-a960-82cb42a6879f 33 fields · synced May 30, 2026
- FDA UDI e4aba2ef-30ff-44db-8c50-1ca118d04252 33 fields · synced May 30, 2026
- FDA UDI dfe51cae-e429-4735-9c54-ec7d01a08c6f 33 fields · synced May 30, 2026
- FDA UDI 6941ae86-f178-44c8-9d41-01dfb1e4540c 33 fields · synced May 30, 2026
- FDA UDI 3effceb2-654a-44b3-a928-6e56d628a76c 33 fields · synced May 30, 2026
- FDA UDI 7635a0e4-b463-411d-b026-02434cca66fd 33 fields · synced May 30, 2026
- FDA UDI fddd9eb7-ecc3-4d25-8730-f9b717bdc87e 33 fields · synced May 30, 2026
- FDA UDI 4c046492-5d47-400a-93d4-67ea871e9bfc 33 fields · synced May 30, 2026
- FDA UDI c8005a8e-51d7-4c47-940e-9dc87965bc4c 33 fields · synced May 30, 2026
- FDA UDI 4343112b-3831-41cd-88e5-2c6f6bc0a29b 33 fields · synced May 30, 2026
- FDA UDI 0cfdb4a0-9372-48b7-aadb-eca8dd2c6376 33 fields · synced May 30, 2026
- FDA UDI db85b4d2-d206-48aa-9a9b-9de109eb2ceb 33 fields · synced May 30, 2026
- FDA UDI eaf9920e-9deb-4fb6-ac14-a3b6c1e8ea0d 33 fields · synced May 30, 2026
- FDA UDI 17b532f3-da20-4f7e-8f78-fd99b2ac31d6 33 fields · synced May 30, 2026
- FDA UDI 22af8b52-082d-4de9-911f-e206fd94231a 33 fields · synced May 30, 2026
- FDA UDI b4c95d6f-1b9d-4f54-aeee-7c8611fa313e 33 fields · synced May 30, 2026
- FDA UDI 9c5bf2d1-8614-45f0-ba17-ee870de7fb37 33 fields · synced May 30, 2026
- FDA UDI 00dbde4e-f9ab-48e6-8d4f-dcbb786d96d4 33 fields · synced May 30, 2026
- EUDAMED ab90fabf-5a8c-40e3-9a0f-6758f83e1ce6 61 fields · synced Jul 8, 2026
- EUDAMED 17b974b4-ea27-4c26-87ac-6c1119767aca 61 fields · synced Jul 9, 2026
- EUDAMED 2f519469-86b4-4cd6-9401-f6c4d1d3fba0 61 fields · synced Jul 9, 2026
- EUDAMED 7605acba-a798-435c-98e5-29f813222f65 61 fields · synced Jul 9, 2026
- EUDAMED 57a9102c-b3ac-48a9-b30e-f1859e674b0b 61 fields · synced Jul 9, 2026
- EUDAMED c4edc1a7-90b7-4eba-9d79-cf58b97251ea 61 fields · synced Jul 9, 2026
- EUDAMED 7c83250d-ea5d-460a-aad8-089efb96b402 61 fields · synced Jul 10, 2026
- EUDAMED 65184b65-b8be-439c-9bce-9f1e40c71dcc 61 fields · synced Jul 10, 2026
- EUDAMED 8e2d961a-0b68-4ccf-9daa-718b3fc08762 61 fields · synced Jul 10, 2026
- EUDAMED 42394a57-b910-469b-bfad-2a0aefb86cd0 61 fields · synced Jul 10, 2026
- EUDAMED ad2e903d-8066-438e-996e-3f6f71fc00b2 61 fields · synced Jul 11, 2026
- EUDAMED a50533c3-57ed-4c41-bebd-f4558ffa39be 61 fields · synced Jul 11, 2026
- EUDAMED b6c51d8b-39d0-4414-9306-1ddc11cad708 61 fields · synced Jul 13, 2026
- EUDAMED cfb75117-5fe1-4c5e-aeda-71ae0b098815 61 fields · synced Jul 14, 2026
- EUDAMED 206ae772-0263-4bc9-964e-9f9265599007 61 fields · synced Jul 14, 2026
- EUDAMED cf5808ee-962a-43ca-aab2-08ea8edbdcde 61 fields · synced Jul 14, 2026
- EUDAMED d298a1e9-a813-4a61-877d-f6bbaac78555 61 fields · synced Jul 15, 2026
- EUDAMED 6b036d66-dc02-4055-8308-aef3bc409885 61 fields · synced Jul 16, 2026
- EUDAMED 7fa95d97-fc1f-4f46-92e1-0ce18ab01310 61 fields · synced Jul 16, 2026
- EUDAMED 7ab7b4f4-a8e0-467e-8581-44b6283fe213 61 fields · synced Jul 16, 2026
- EUDAMED bb4ea4ce-ff0a-4b65-b14a-d941ae462d15 61 fields · synced Jul 18, 2026
- EUDAMED 45e79f33-ae9b-488f-89e5-14509df8f552 61 fields · synced Jul 19, 2026
- EUDAMED ca816548-8c6a-4424-93ec-144fb2abacba 61 fields · synced Jul 19, 2026
- EUDAMED a49e7594-0501-4388-b6b4-0a1227406e08 61 fields · synced Jul 21, 2026
- EUDAMED c6bd8c25-a013-41ab-8fe1-2f334cc1696c 61 fields · synced Jul 21, 2026
- EUDAMED b85a45c8-bdf1-421c-b87b-9668ad1632e8 61 fields · synced Jul 22, 2026
- EUDAMED 32083967-7a7e-40d2-b175-bf171bc0ddbd 61 fields · synced Jul 24, 2026
- EUDAMED aba408f3-09a7-4939-85f0-d25e67f97daf 61 fields · synced Jul 25, 2026
- EUDAMED 97875760-788e-4c3c-a7f1-e31ba054c069 61 fields · synced Jul 26, 2026
- EUDAMED 23559a53-0d65-426c-b16e-b073e9104abf 61 fields · synced Jul 26, 2026
- EUDAMED a4172614-0ef3-449d-88a6-c1a285b6d7e5 61 fields · synced Jul 26, 2026
- EUDAMED ad8887b5-78de-4abd-a08f-9bf94a0c7f35 61 fields · synced Jul 27, 2026
- EUDAMED 3a8d2c9e-12a9-4c4b-8da5-50af9a535956 61 fields · synced Jul 31, 2026
- EUDAMED 19dd226d-ac58-467d-a1fe-86aba62a0264 61 fields · synced Aug 2, 2026
- EUDAMED 141479c4-e024-42ff-91a0-99196c0691ff 61 fields · synced Aug 3, 2026
- EUDAMED 2cefc46c-865c-4d05-9971-0315c8cd188e 61 fields · synced Aug 4, 2026
- EUDAMED f3778dbf-abce-45aa-b3b4-ca0616b35e8b 61 fields · synced Aug 4, 2026
- EUDAMED b457db37-7d70-4893-8222-0a3bd49b9cf9 61 fields · synced Sep 17, 2026