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NB I Fixture

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref NB15513SSRef NB13613SSRef NB14513SSRef NB15510SSRef NB16506SPRef NB14511SPRef NB15013SPRef NB16006SPRef NB16011SPRef NB14507SSRef NB15007SSRef NB14007SSRef NB16008SPRef NB16507SPRef NB15011SPRef NB15506SSRef NB15506SPRef NB13610SPRef NB16513SPRef NB15008SPRef NB16010SSRef NB14010SSRef NB15508SSRef NB14008SSRef NB15008SSRef NB15010SSRef NB13608SSRef NB16508SPRef NB14510SSRef NB16006SSRef NB14013SPRef NB14011SPRef NB16513SSRef NB15510SPRef NB16013SPRef NB16511SSRef NB16510SPRef NB14510SPRef NB15011SSRef NB14513SPRef NB15513SPRef NB15511SSRef NB14507SPRef NB15507SSRef NB16507SSRef NB13611SP

by ARUM DENTISTRY Co., Ltd.

Identity

Trade Name
NB I Fixture EUDAMEDFDA UDI
Generic Name
Screw endosteal dental implant, two-piece FDA UDI
Device Name
Dental Implant Fixture EUDAMED
Model / Reference
NB16506SP EUDAMEDFDA UDI
NB14511SP EUDAMEDFDA UDI
NB16507SS EUDAMEDFDA UDI
NB14513SS EUDAMEDFDA UDI
NB16511SS EUDAMEDFDA UDI
NB16508SP EUDAMEDFDA UDI
NB15011SP EUDAMEDFDA UDI
NB15013SP EUDAMEDFDA UDI
NB16013SP EUDAMEDFDA UDI
NB15010SS EUDAMEDFDA UDI
NB16006SS EUDAMEDFDA UDI
NB14513SP EUDAMEDFDA UDI
NB14510SP EUDAMEDFDA UDI
NB14507SP EUDAMEDFDA UDI
NB14010SS EUDAMEDFDA UDI
NB15008SS EUDAMEDFDA UDI
NB14011SP EUDAMEDFDA UDI
NB14013SP EUDAMEDFDA UDI
NB15011SS EUDAMEDFDA UDI
NB14510SS EUDAMEDFDA UDI
NB15008SP EUDAMEDFDA UDI
NB15510SP EUDAMEDFDA UDI
NB15513SS EUDAMEDFDA UDI
NB15506SS EUDAMEDFDA UDI
NB13608SS EUDAMEDFDA UDI
NB16513SS EUDAMEDFDA UDI
NB16513SP EUDAMEDFDA UDI
NB13610SP EUDAMEDFDA UDI
NB16510SP EUDAMEDFDA UDI
NB13613SS EUDAMEDFDA UDI
NB14007SS EUDAMEDFDA UDI
NB16006SP EUDAMEDFDA UDI
NB16507SP EUDAMEDFDA UDI
NB15513SP EUDAMEDFDA UDI
NB15508SS EUDAMEDFDA UDI
NB15510SS EUDAMEDFDA UDI
NB16008SP EUDAMEDFDA UDI
NB16011SP EUDAMEDFDA UDI
NB14008SS EUDAMEDFDA UDI
NB16010SS EUDAMEDFDA UDI
NB13611SP EUDAMEDFDA UDI
NB15506SP EUDAMEDFDA UDI
NB15507SS EUDAMEDFDA UDI
NB14507SS EUDAMEDFDA UDI
NB15007SS EUDAMEDFDA UDI
NB15511SS EUDAMEDFDA UDI
NB15007SP FDA UDI

Identifiers

Primary DI / UDI-DI
08800055794549 EUDAMEDFDA UDI
08800055794358 EUDAMEDFDA UDI
08809917605252 EUDAMEDFDA UDI
08809917605047 EUDAMEDFDA UDI
08809917605283 EUDAMEDFDA UDI
08800055794563 EUDAMEDFDA UDI
08800055794402 EUDAMEDFDA UDI
08800055794419 EUDAMEDFDA UDI
08800055794532 EUDAMEDFDA UDI
08809917605061 EUDAMEDFDA UDI
08809917605184 EUDAMEDFDA UDI
08800055794365 EUDAMEDFDA UDI
08800055794341 EUDAMEDFDA UDI
08800055794327 EUDAMEDFDA UDI
08809917604989 EUDAMEDFDA UDI
08809917605054 EUDAMEDFDA UDI
08800055794303 EUDAMEDFDA UDI
08800055794310 EUDAMEDFDA UDI
08809917605078 EUDAMEDFDA UDI
08809917605023 EUDAMEDFDA UDI
08800055794389 EUDAMEDFDA UDI
08800055794457 EUDAMEDFDA UDI
08809917605177 EUDAMEDFDA UDI
08809917605122 EUDAMEDFDA UDI
08800055793153 EUDAMEDFDA UDI
08809917605290 EUDAMEDFDA UDI
08800055794594 EUDAMEDFDA UDI
08800055793191 EUDAMEDFDA UDI
08800055794570 EUDAMEDFDA UDI
08800055793184 EUDAMEDFDA UDI
08809917605092 EUDAMEDFDA UDI
08800055794488 EUDAMEDFDA UDI
08800055794556 EUDAMEDFDA UDI
08800055794471 EUDAMEDFDA UDI
08809917605146 EUDAMEDFDA UDI
08809917605153 EUDAMEDFDA UDI
08800055794501 EUDAMEDFDA UDI
08800055794525 EUDAMEDFDA UDI
08809917604972 EUDAMEDFDA UDI
08809917605214 EUDAMEDFDA UDI
08800055793207 EUDAMEDFDA UDI
08800055794426 EUDAMEDFDA UDI
08809917605139 EUDAMEDFDA UDI
08809917605108 EUDAMEDFDA UDI
08809917605115 EUDAMEDFDA UDI
08809917605160 EUDAMEDFDA UDI
08800055794372 FDA UDI
Basic UDI-DI
88000557FIXXG EUDAMED
510(k) Number
K213506 FDA UDI
FDA Product Code
DZE FDA UDI
EMDN Code
P01020101 DENTAL IMPLANTS EUDAMED
GMDN Term
Screw endosteal dental implant, two-piece FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class 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
MRI Safety
MR Conditional FDA UDI

Category: Screw endosteal dental implant, two-piece

NB I 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.

Cleared under the same submission

K213506 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
ARUM DENTISTRY Co., Ltd.

Sources (93)

  • FDA UDI c7d5c0bd-bef1-4d06-8664-4e44009af1bd 33 fields · synced Sep 18, 2026
  • FDA UDI a8fa260e-0293-41d3-938b-741b8ea34290 33 fields · synced May 24, 2026
  • FDA UDI 23600bad-12e3-4906-bfc1-647391700158 33 fields · synced May 24, 2026
  • FDA UDI 34c96658-f31b-49a3-8378-51e8ccdd288e 33 fields · synced May 25, 2026
  • FDA UDI 52dbc8dd-342a-4283-97e9-d3b85126d613 33 fields · synced May 25, 2026
  • FDA UDI aef6f109-0c1f-4e80-9b52-c39424be1f50 33 fields · synced May 27, 2026
  • FDA UDI 7577d372-c087-4401-955b-7fa0195ac055 33 fields · synced May 27, 2026
  • FDA UDI d07c58b9-44d6-4a59-8147-610e3ec5410d 33 fields · synced May 29, 2026
  • FDA UDI 19e20d20-65ef-454f-9361-f643c60a9b17 33 fields · synced May 29, 2026
  • FDA UDI 7f2b760e-e2b3-4afd-a695-0461b5c2473c 33 fields · synced May 29, 2026
  • FDA UDI 6ff12b63-936c-4051-a9a2-6e09b847828f 33 fields · synced May 29, 2026
  • FDA UDI 4901be91-12c4-4245-9541-904765417142 33 fields · synced May 29, 2026
  • FDA UDI fc6dc3e6-5486-4d42-ac33-a098d546aa7b 33 fields · synced May 29, 2026
  • FDA UDI 50a8eaf5-663c-4626-934b-cadaa589c8ec 33 fields · synced May 30, 2026
  • FDA UDI fd74b32e-87d2-41a9-a2f8-06543bf7bc47 33 fields · synced May 30, 2026
  • FDA UDI 0bef51d3-1fd6-4345-a7c9-f5929b78818a 33 fields · synced May 30, 2026
  • FDA UDI 49ed4567-7b70-4456-b19c-be434120c66d 33 fields · synced May 30, 2026
  • FDA UDI be84f969-2f82-4e26-9e20-39363effab08 33 fields · synced May 30, 2026
  • FDA UDI eebdad14-24b0-4b6d-a5bd-eee1def4124e 33 fields · synced May 30, 2026
  • FDA UDI 4c8f499b-0de9-45e8-b0c7-377ba025ec6f 33 fields · synced May 30, 2026
  • FDA UDI b65b1e99-0ba9-46c5-a0f7-898819d2c97c 33 fields · synced May 30, 2026
  • FDA UDI 001a5892-1e50-4c77-859d-9c8dd2f59b75 33 fields · synced May 30, 2026
  • FDA UDI b1e50780-b45a-456d-9ece-78e3f750e327 33 fields · synced May 30, 2026
  • FDA UDI e992e830-4124-4722-80e1-e3fbb0050a32 33 fields · synced May 30, 2026
  • FDA UDI 21d7669a-9132-4953-b2ad-2656157027af 33 fields · synced May 30, 2026
  • FDA UDI 403bb87f-2e45-45bf-805c-7194a3c1ebbd 33 fields · synced May 30, 2026
  • FDA UDI 7e142fbb-8bb5-4820-836f-3520334233cf 33 fields · synced May 30, 2026
  • FDA UDI 94302e04-d0cf-4856-80c5-3a80d7ea9c0f 33 fields · synced May 30, 2026
  • FDA UDI f3c44cae-f86c-4ab8-874d-22b87803b1a6 33 fields · synced May 30, 2026
  • FDA UDI 5d41e225-76ed-440a-b4d2-c11865033ad7 33 fields · synced May 30, 2026
  • FDA UDI bce2d695-5093-4fa3-97ce-6355e37a1988 33 fields · synced May 30, 2026
  • FDA UDI 7c8dfc90-a5e1-453d-b2d5-fc51f751da71 33 fields · synced May 30, 2026
  • FDA UDI 38ab7bbe-2517-4464-b33d-2aec43a73fb2 33 fields · synced May 30, 2026
  • FDA UDI ad7fb053-3cd2-49ca-a554-f4a04f2ce85c 33 fields · synced May 30, 2026
  • FDA UDI 5699f02b-251c-44dd-8ed9-c0806294519d 33 fields · synced May 30, 2026
  • FDA UDI 4a76da2a-4089-48d7-8771-c7a284c68b50 33 fields · synced May 30, 2026
  • FDA UDI 19bc08bc-7789-4387-9e8f-ef699370c94e 33 fields · synced May 30, 2026
  • FDA UDI f197f560-6998-4168-9a28-69778b46383d 33 fields · synced May 30, 2026
  • FDA UDI ad30319e-1e9c-46ab-a6a2-97ef95677ad6 33 fields · synced May 30, 2026
  • FDA UDI e4515850-d258-4886-846e-dc1813ec6fbf 33 fields · synced May 30, 2026
  • FDA UDI 49e31844-8143-4244-bc93-32c11bc27418 33 fields · synced May 30, 2026
  • FDA UDI 5eb59c3b-90d3-4b24-bed7-4355d46acacf 33 fields · synced May 30, 2026
  • FDA UDI 06b4ca98-4fd1-45ac-bac2-160c4143a65f 33 fields · synced May 30, 2026
  • FDA UDI 33dc952c-86f0-46bb-ac6d-ba8f4fb42a53 32 fields · synced May 30, 2026
  • FDA UDI b4fe297d-5318-4e47-9618-f37aae1e233c 33 fields · synced May 30, 2026
  • FDA UDI b94d11db-9334-4159-b7ae-21905570a344 33 fields · synced May 30, 2026
  • FDA UDI c46225cf-c0e3-424e-a288-54df9f1ea6e3 33 fields · synced May 30, 2026
  • EUDAMED 75da453c-40c1-437d-9882-bb65080592b9 61 fields · synced Jun 20, 2026
  • EUDAMED 80c6776b-1664-4220-9bfa-de8883a139fd 61 fields · synced Jul 8, 2026
  • EUDAMED 9c27efa1-acf0-4481-a130-7016c5b29f79 61 fields · synced Jul 8, 2026
  • EUDAMED 71a39374-c6cb-4d2b-a2d7-ab6aa5149651 61 fields · synced Jul 9, 2026
  • EUDAMED 6789dc40-40d9-4eb7-a61b-3270f92a8c5e 61 fields · synced Jul 9, 2026
  • EUDAMED f04ad9a4-15f2-4839-9b49-ad807a16417f 61 fields · synced Jul 9, 2026
  • EUDAMED e137cf09-7fdd-4448-8c62-0653249596ab 61 fields · synced Jul 9, 2026
  • EUDAMED 1b7c8989-873e-47aa-bb57-c2b8919e8798 61 fields · synced Jul 9, 2026
  • EUDAMED 4962a9b1-c30e-4a32-8252-af8d79fc665d 61 fields · synced Jul 9, 2026
  • EUDAMED 9739f4e3-b43a-4830-b930-5ccc071d52ae 61 fields · synced Jul 10, 2026
  • EUDAMED 3d290bd7-0667-47b4-9eba-58a10044e1a9 61 fields · synced Jul 10, 2026
  • EUDAMED 8b45313f-806c-4775-a9b8-21a542b0392a 61 fields · synced Jul 11, 2026
  • EUDAMED 9599ad0f-3c9f-4241-9b8f-498bc6f420de 61 fields · synced Jul 11, 2026
  • EUDAMED a344d0d6-2f01-43fc-83f0-cfe177a9991f 61 fields · synced Jul 11, 2026
  • EUDAMED 18536f63-b9e3-4b3b-a50d-1f8a4294fc4f 61 fields · synced Jul 12, 2026
  • EUDAMED acd4655b-518c-4851-bb63-85d4ba5c54b4 61 fields · synced Jul 14, 2026
  • EUDAMED d5a42415-1466-4e28-a943-838c655c5357 61 fields · synced Jul 14, 2026
  • EUDAMED 4de8da9d-f97f-4f87-b80f-9bc70d2a4733 61 fields · synced Jul 14, 2026
  • EUDAMED 96617f4d-1771-48fb-818f-6746214af250 61 fields · synced Jul 14, 2026
  • EUDAMED a24a9523-96cb-4dc1-91c3-22097beb6a21 61 fields · synced Jul 15, 2026
  • EUDAMED f4bf0ddd-0ed6-450d-b1c5-821c9d5886e7 61 fields · synced Jul 16, 2026
  • EUDAMED a37a031a-9a04-4c9b-be1b-0a3c35d0795f 61 fields · synced Jul 17, 2026
  • EUDAMED 421121f5-548d-43cb-8ad3-0d8fe384e6c4 61 fields · synced Jul 17, 2026
  • EUDAMED 56080b64-3e16-41ed-9b0e-ec71d9206137 61 fields · synced Jul 19, 2026
  • EUDAMED 3a589b79-653b-469d-a98d-4e52541a01ee 61 fields · synced Jul 20, 2026
  • EUDAMED 8ddf123f-ff37-4d54-b88c-05d2fe04f6b2 61 fields · synced Jul 22, 2026
  • EUDAMED 07ea5a6e-fb68-468c-8295-ebf8820646ab 61 fields · synced Jul 23, 2026
  • EUDAMED 3506ff3f-a3f7-4ede-846c-68101596baa8 61 fields · synced Jul 24, 2026
  • EUDAMED 8d98df9d-e691-4589-97cb-7d074bcd1ab4 61 fields · synced Jul 24, 2026
  • EUDAMED aced58a4-0357-4d05-b9dc-dfa02fe8e517 61 fields · synced Jul 25, 2026
  • EUDAMED f073d1a8-6b00-48e1-8cc0-6833b6e32c70 61 fields · synced Jul 26, 2026
  • EUDAMED 90f0e23e-ca25-4215-907f-0149c30ea1b4 61 fields · synced Jul 27, 2026
  • EUDAMED ec86d554-a1c6-494f-a441-a615bdb209dc 61 fields · synced Jul 28, 2026
  • EUDAMED be260500-3e23-4059-a0a4-106a7980e378 61 fields · synced Jul 28, 2026
  • EUDAMED c722f50d-2a33-439a-875a-4dfd525c468a 61 fields · synced Jul 28, 2026
  • EUDAMED be0c5b7c-9473-4d39-8129-844c3b39ea01 61 fields · synced Jul 28, 2026
  • EUDAMED af88c7f8-39d3-4c88-b71f-af20524f32ca 61 fields · synced Jul 28, 2026
  • EUDAMED c5965b17-a293-4440-b52a-8016f3cc7ca3 61 fields · synced Jul 29, 2026
  • EUDAMED d2bccd34-13c5-49af-904b-0abdc2ecd71d 61 fields · synced Jul 29, 2026
  • EUDAMED f6d9855d-9c5b-4b58-bfcd-ef4bea444e37 61 fields · synced Jul 30, 2026
  • EUDAMED 5854795d-4e3e-41c9-97a7-5877172a52c7 61 fields · synced Jul 31, 2026
  • EUDAMED 53251d01-ab59-4884-9f5e-cc473004e7c9 61 fields · synced Aug 1, 2026
  • EUDAMED 13be94e4-c258-408a-9f4a-3db68040ab49 61 fields · synced Aug 2, 2026
  • EUDAMED b9ce7611-5c53-4df5-8209-47439e7d3947 61 fields · synced Aug 4, 2026
  • EUDAMED d45dfbc8-60e3-4e2f-9680-412c209ed8fd 61 fields · synced Sep 17, 2026
  • EUDAMED 5ea6382b-8e84-4fc7-bc6b-eb7ad36e90cd 61 fields · synced Sep 18, 2026