Ok Real Resin Bracket

EUDAMED

Class IIa (EU MDR)

Ref 650-553Model 650-553 OK BRACKET STD 022Ref 610-031Model 610-031 OK BRACKET ROTH 022Ref 630-43H-5Model OK BRACKET MBT 022 #43HRef 620-44H-5Model OK BRACKET MBT 018 #44HRef 650-23H-5Model OK BRACKET STD 022 #23HRef 620-34H-5Model OK BRACKET MBT 018 #34HRef 670-45-5Model 670-45 OK ROTH 022 #45Ref 690-031Model 690-031 OK MBT 022 0*3 H3Ref 620-031Model 620-031 OK BRACKET MBT 018Ref 640-331Model 640-331 OK BRACKET STD 018Ref 650-031Model 650-031 OK BRACKET STD 022Ref 630-12-5Model OK BRACKET MBT 022 #12Ref 600-551Model 600-551 OK BRACKET ROTH 018Ref 670-331Model 670-331 OK ROTH 022 3*3 H3Ref 600-31-5Model OK BRACKET ROTH 018 #31Ref 600-11-5 Model OK BRACKET ROTH 018 #11Ref 610-34-5 Model OK BRACKET ROTH 022 #34Ref 600-44-5Model OK BRACKET ROTH 018 #44Ref 620-553Model 620-553 OK BRACKET MBT 018Ref 660-43H-5Model 660-43H OK ROTH 018 #43HRef 620-301Model 620-301 OK BRACKET MBT 018Ref 640-553Model 640-553 OK BRACKET STD 018Ref 630-22-5Model OK BRACKET MBT 022 #22Ref 600-051Model 600-051 OK BRACKET ROTH 018Ref 610-33H-5Model OK BRACKET ROTH 022 #33HRef 660-551Model 660-551 OK ROTH 018 5*5 H3Ref 600-21-5Model OK BRACKET ROTH 018 #21Ref 610-23H-5Model OK BRACKET ROTH 022 #23HRef 620-23H-5Model OK BRACKET MBT 018 #23HRef 631-051Model OK M-022 0*5 (R_#4,5) H3 LRef 630-33H-5Model OK BRACKET MBT 022 #33HRef 600-33H-5Model OK BRACKET ROTH 018 #33HRef 600-331Model 600-331 OK BRACKET ROTH 018Ref 610-31-5Model OK BRACKET ROTH 022 #31Ref 650-053Model 650-053 OK BRACKET STD 022Ref 610-22-5Model OK BRACKET ROTH 022 #22Ref 690-331Model 690-331 OK MBT 022 3*3 H3Ref 630-553Model 630-553 OK BRACKET MBT 022Ref 630-331Model 630-331 OK BRACKET MBT 022Ref 620-22-5Model OK BRACKET MBT 018 #22Ref 610-551Model 610-551 OK BRACKET ROTH 022Ref 670-551Model 670-551 OK ROTH 022 5*5 H3Ref 610-501Model 610-501 OK BRACKET ROTH 022Ref 600-13H-5Model OK BRACKET ROTH 018 #13HRef 613-053Model OK R-022 0*5 (M_#4,5) H345 LRef 670-35-5Model 670-35 OK ROTH 022 #35Ref 620-503Model 620-503 OK BRACKET MBT 018Ref 610-21-5Model OK BRACKET ROTH 022 #21Ref 610-24-5Model OK BRACKET ROTH 022 #24Ref 630-11-5Model OK BRACKET MBT 022 #11Ref 640-031Model 640-031 OK BRACKET STD 018Ref 690-33H-5Model 690-33H OK MBT 022 #33HRef 660-051Model 660-051 OK ROTH 018 0*5 H3Ref 600-43H-5Model OK BRACKET ROTH 018 #43HRef 690-35H-5Model 690-35H OK MBT 022 #35HRef 610-43H-5 Model OK BRACKET ROTH 022 #43HRef 630-31-5Model OK BRACKET MBT 022 #31

by Osstem Orthodontics Inc.

Identity

Trade Name: OK REAL RESIN BRACKET EUDAMED
Model / Reference: 650-553 OK BRACKET STD 022 EUDAMED
650-553 EUDAMED
610-031 OK BRACKET ROTH 022 EUDAMED
610-031 EUDAMED
OK BRACKET MBT 022 #43H EUDAMED
630-43H-5 EUDAMED
OK BRACKET MBT 018 #44H EUDAMED
620-44H-5 EUDAMED
OK BRACKET STD 022 #23H EUDAMED
650-23H-5 EUDAMED
OK BRACKET MBT 018 #34H EUDAMED
620-34H-5 EUDAMED
670-45 OK ROTH 022 #45 EUDAMED
670-45-5 EUDAMED
690-031 OK MBT 022 0*3 H3 EUDAMED
690-031 EUDAMED
620-031 OK BRACKET MBT 018 EUDAMED
620-031 EUDAMED
640-331 OK BRACKET STD 018 EUDAMED
640-331 EUDAMED
650-031 OK BRACKET STD 022 EUDAMED
650-031 EUDAMED
OK BRACKET MBT 022 #12 EUDAMED
630-12-5 EUDAMED
600-551 OK BRACKET ROTH 018 EUDAMED
600-551 EUDAMED
670-331 OK ROTH 022 3*3 H3 EUDAMED
670-331 EUDAMED
OK BRACKET ROTH 018 #31 EUDAMED
600-31-5 EUDAMED
OK BRACKET ROTH 018 #11 EUDAMED
600-11-5 EUDAMED
OK BRACKET ROTH 022 #34 EUDAMED
610-34-5 EUDAMED
OK BRACKET ROTH 018 #44 EUDAMED
600-44-5 EUDAMED
620-553 OK BRACKET MBT 018 EUDAMED
620-553 EUDAMED
660-43H OK ROTH 018 #43H EUDAMED
660-43H-5 EUDAMED
620-301 OK BRACKET MBT 018 EUDAMED
620-301 EUDAMED
640-553 OK BRACKET STD 018 EUDAMED
640-553 EUDAMED
OK BRACKET MBT 022 #22 EUDAMED
630-22-5 EUDAMED
600-051 OK BRACKET ROTH 018 EUDAMED
600-051 EUDAMED
OK BRACKET ROTH 022 #33H EUDAMED
610-33H-5 EUDAMED
660-551 OK ROTH 018 5*5 H3 EUDAMED
660-551 EUDAMED
OK BRACKET ROTH 018 #21 EUDAMED
600-21-5 EUDAMED
OK BRACKET ROTH 022 #23H EUDAMED
610-23H-5 EUDAMED
OK BRACKET MBT 018 #23H EUDAMED
620-23H-5 EUDAMED
OK M-022 0*5 (R_#4,5) H3 L EUDAMED
631-051 EUDAMED
OK BRACKET MBT 022 #33H EUDAMED
630-33H-5 EUDAMED
OK BRACKET ROTH 018 #33H EUDAMED
600-33H-5 EUDAMED
600-331 OK BRACKET ROTH 018 EUDAMED
600-331 EUDAMED
OK BRACKET ROTH 022 #31 EUDAMED
610-31-5 EUDAMED
650-053 OK BRACKET STD 022 EUDAMED
650-053 EUDAMED
OK BRACKET ROTH 022 #22 EUDAMED
610-22-5 EUDAMED
690-331 OK MBT 022 3*3 H3 EUDAMED
690-331 EUDAMED
630-553 OK BRACKET MBT 022 EUDAMED
630-553 EUDAMED
630-331 OK BRACKET MBT 022 EUDAMED
630-331 EUDAMED
OK BRACKET MBT 018 #22 EUDAMED
620-22-5 EUDAMED
610-551 OK BRACKET ROTH 022 EUDAMED
610-551 EUDAMED
670-551 OK ROTH 022 5*5 H3 EUDAMED
670-551 EUDAMED
610-501 OK BRACKET ROTH 022 EUDAMED
610-501 EUDAMED
OK BRACKET ROTH 018 #13H EUDAMED
600-13H-5 EUDAMED
OK R-022 0*5 (M_#4,5) H345 L EUDAMED
613-053 EUDAMED
670-35 OK ROTH 022 #35 EUDAMED
670-35-5 EUDAMED
620-503 OK BRACKET MBT 018 EUDAMED
620-503 EUDAMED
OK BRACKET ROTH 022 #21 EUDAMED
610-21-5 EUDAMED
OK BRACKET ROTH 022 #24 EUDAMED
610-24-5 EUDAMED
OK BRACKET MBT 022 #11 EUDAMED
630-11-5 EUDAMED
640-031 OK BRACKET STD 018 EUDAMED
640-031 EUDAMED
690-33H OK MBT 022 #33H EUDAMED
690-33H-5 EUDAMED
660-051 OK ROTH 018 0*5 H3 EUDAMED
660-051 EUDAMED
OK BRACKET ROTH 018 #43H EUDAMED
600-43H-5 EUDAMED
690-35H OK MBT 022 #35H EUDAMED
690-35H-5 EUDAMED
OK BRACKET ROTH 022 #43H EUDAMED
610-43H-5 EUDAMED
OK BRACKET MBT 022 #31 EUDAMED
630-31-5 EUDAMED

Identifiers

Primary DI / UDI-DI: 08800033403975 EUDAMED
08800033403685 EUDAMED
08800033402275 EUDAMED
08800033401797 EUDAMED
08800033403593 EUDAMED
08800033401711 EUDAMED
08800033466413 EUDAMED
08800033466680 EUDAMED
08800033403746 EUDAMED
08800033403890 EUDAMED
08800033403920 EUDAMED
08800033401872 EUDAMED
08800033403678 EUDAMED
08800033466666 EUDAMED
08800033402671 EUDAMED
08800033402350 EUDAMED
08800033403272 EUDAMED
08800033402831 EUDAMED
08800033403791 EUDAMED
08800033466215 EUDAMED
08800033403760 EUDAMED
08800033403913 EUDAMED
08800033402039 EUDAMED
08800033403630 EUDAMED
08800033403234 EUDAMED
08800033466635 EUDAMED
08800033402510 EUDAMED
08800033403111 EUDAMED
08800033401551 EUDAMED
08800033466758 EUDAMED
08800033402190 EUDAMED
08800033402718 EUDAMED
08800033403654 EUDAMED
08800033403197 EUDAMED
08800033403937 EUDAMED
08800033403074 EUDAMED
08800033466703 EUDAMED
08800033403852 EUDAMED
08800033403838 EUDAMED
08800033401513 EUDAMED
08800033403739 EUDAMED
08800033466673 EUDAMED
08800033403722 EUDAMED
08800033402435 EUDAMED
08800033466734 EUDAMED
08800033466338 EUDAMED
08800033403784 EUDAMED
08800033403036 EUDAMED
08800033403159 EUDAMED
08800033401834 EUDAMED
08800033403869 EUDAMED
08800033466451 EUDAMED
08800033466611 EUDAMED
08800033402794 EUDAMED
08800033466499 EUDAMED
08800033403319 EUDAMED
08800033402152 EUDAMED
Basic UDI-DI: B-08800033403975 EUDAMED
B-08800033403685 EUDAMED
B-08800033402275 EUDAMED
B-08800033401797 EUDAMED
B-08800033403593 EUDAMED
B-08800033401711 EUDAMED
B-08800033466413 EUDAMED
B-08800033466680 EUDAMED
B-08800033403746 EUDAMED
B-08800033403890 EUDAMED
B-08800033403920 EUDAMED
B-08800033401872 EUDAMED
B-08800033403678 EUDAMED
B-08800033466666 EUDAMED
B-08800033402671 EUDAMED
B-08800033402350 EUDAMED
B-08800033403272 EUDAMED
B-08800033402831 EUDAMED
B-08800033403791 EUDAMED
B-08800033466215 EUDAMED
B-08800033403760 EUDAMED
B-08800033403913 EUDAMED
B-08800033402039 EUDAMED
B-08800033403630 EUDAMED
B-08800033403234 EUDAMED
B-08800033466635 EUDAMED
B-08800033402510 EUDAMED
B-08800033403111 EUDAMED
B-08800033401551 EUDAMED
B-08800033466758 EUDAMED
B-08800033402190 EUDAMED
B-08800033402718 EUDAMED
B-08800033403654 EUDAMED
B-08800033403197 EUDAMED
B-08800033403937 EUDAMED
B-08800033403074 EUDAMED
B-08800033466703 EUDAMED
B-08800033403852 EUDAMED
B-08800033403838 EUDAMED
B-08800033401513 EUDAMED
B-08800033403739 EUDAMED
B-08800033466673 EUDAMED
B-08800033403722 EUDAMED
B-08800033402435 EUDAMED
B-08800033466734 EUDAMED
B-08800033466338 EUDAMED
B-08800033403784 EUDAMED
B-08800033403036 EUDAMED
B-08800033403159 EUDAMED
B-08800033401834 EUDAMED
B-08800033403869 EUDAMED
B-08800033466451 EUDAMED
B-08800033466611 EUDAMED
B-08800033402794 EUDAMED
B-08800033466499 EUDAMED
B-08800033403319 EUDAMED
B-08800033402152 EUDAMED
EMDN Code: Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Spain EUDAMED
Germany EUDAMED
Bulgaria EUDAMED
Italy EUDAMED
Croatia EUDAMED
Luxembourg EUDAMED
Türkiye EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Category: Orthodontic tube

Ok Real Resin Bracket by Osstem Orthodontics Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic tube.

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Metal bracket conventional — Bernhard Förster GmbH · Class IIa
Master Series Bracket — American Orthodontics · Class IIa
CASO KIRIONE ROTH .022 7X7 (3-4-5) C/10 — ID-LOGICAL INDUSTRIA E COMERCIO LTDA · Class IIa
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Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-08800033403975	Class IIa	Active

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

Manufacturer

Manufacturer: Osstem Orthodontics Inc.
EUDAMED SRN: KR-MF-000021559
Authorised Representative: AR Experts B.V. NL-AR-000023989

Sources (57)

EUDAMED 3312c0e2-cfe1-4965-87ac-c84d0baf0b75 61 fields · synced Sep 17, 2026
EUDAMED 48a9bb9e-e8ef-47d0-bcd4-351447180155 61 fields · synced May 11, 2026
EUDAMED 562f830e-8a43-49bc-8021-e0cabec889ae 61 fields · synced May 11, 2026
EUDAMED 5ea93dfa-4518-4120-abc0-1fdccf11a5ea 61 fields · synced May 11, 2026
EUDAMED 16298541-2f1c-4958-9143-9c4f7d599632 61 fields · synced May 11, 2026
EUDAMED 169f3078-b173-413d-82e8-3b8acd376807 61 fields · synced May 11, 2026
EUDAMED 5ea95ea2-749c-41c1-857e-5bb4b7019564 61 fields · synced May 16, 2026
EUDAMED 00393823-c295-4826-84f3-7e24df30bfe2 61 fields · synced May 16, 2026
EUDAMED 4fd05e45-c398-4366-88da-790d240c9158 61 fields · synced May 16, 2026
EUDAMED 8e5da968-9bff-479f-ad70-e8257f5e914a 61 fields · synced May 16, 2026
EUDAMED d9461295-1d92-4185-9050-cb7e133fde93 61 fields · synced May 16, 2026
EUDAMED b180b451-1684-4a49-99f0-48bc3ac7c18b 61 fields · synced May 16, 2026
EUDAMED f19e65cd-8c05-43e7-9d21-072bc525f813 61 fields · synced May 16, 2026
EUDAMED 312ffe8f-1586-46f3-8110-7b86204bf62f 61 fields · synced May 17, 2026
EUDAMED 06d86f11-c5c3-48ae-a449-06bf10bc8e1b 61 fields · synced May 17, 2026
EUDAMED db4b5d6c-6332-4cbc-8684-27aeb2e631f1 61 fields · synced May 17, 2026
EUDAMED 13975ea4-a2ed-4c6f-9c8c-94ee40ecb242 61 fields · synced May 17, 2026
EUDAMED 00799c2e-337d-4c1f-b51d-bc74cc43c7f9 61 fields · synced May 17, 2026
EUDAMED cd8ef11b-6725-422e-a07a-2904ccab542c 61 fields · synced May 17, 2026
EUDAMED 8b93db90-fd43-4a68-92a6-061c85662174 61 fields · synced May 17, 2026
EUDAMED a2561af7-54a0-4e15-91c4-afd804c9f74f 61 fields · synced May 17, 2026
EUDAMED e63941f0-8528-4667-9c9a-020c005a209a 61 fields · synced May 17, 2026
EUDAMED 51c9cced-6cda-44b5-b943-2b662803bcf9 61 fields · synced May 17, 2026
EUDAMED 3b8699ee-8c0a-47a7-a108-654680c82888 61 fields · synced May 17, 2026
EUDAMED 489fd0d8-1361-4080-b93d-b6942122897e 61 fields · synced May 17, 2026
EUDAMED 967fda85-4454-469f-a029-764379ab3813 61 fields · synced May 17, 2026
EUDAMED 97eb588a-1d74-4de6-b28a-bee8ece6c574 61 fields · synced May 17, 2026
EUDAMED ac917d49-c235-465c-a860-a99eba1f312b 61 fields · synced May 17, 2026
EUDAMED aa0a8c4f-c7d6-4dd8-85c2-0c3549fceb7c 61 fields · synced May 17, 2026
EUDAMED 76f78675-ad31-46a3-8b04-adeb72d497f1 61 fields · synced May 17, 2026
EUDAMED 55c47443-4884-44fa-b43e-4a66337e8855 61 fields · synced May 17, 2026
EUDAMED 3ac32455-efcf-4d32-b82a-c3ba24db1de3 61 fields · synced May 17, 2026
EUDAMED c009160c-c534-4364-aaff-17238a7ac4b9 61 fields · synced May 18, 2026
EUDAMED 27a52c1b-8e1a-4379-9738-a61b2bb63aa0 61 fields · synced May 18, 2026
EUDAMED e01dba8b-445f-41b7-962d-3b15b58ca453 61 fields · synced May 18, 2026
EUDAMED 37c2bdbd-bb34-4efb-bfd5-b9c49b238382 61 fields · synced May 18, 2026
EUDAMED 07fc14e3-f64e-4dfd-a4f4-ba4527691d68 61 fields · synced May 18, 2026
EUDAMED 0e254606-6b5f-4255-bfb8-8a40f374caec 61 fields · synced May 18, 2026
EUDAMED 39afe712-96b2-4167-b3d1-a6a35845161c 61 fields · synced May 18, 2026
EUDAMED 356dd8e7-ef55-462c-98e9-eb78a79c36ab 61 fields · synced May 18, 2026
EUDAMED 8b79e3ce-e22b-42d4-9374-15cb7c3094af 61 fields · synced May 18, 2026
EUDAMED 381b40ec-9832-4863-9d41-7d09f5b16cd4 61 fields · synced May 18, 2026
EUDAMED 5146811d-eb17-4dab-a358-0139f026c4c3 61 fields · synced May 18, 2026
EUDAMED dc206bc7-aa07-41a7-ab94-b6e35ca533cb 61 fields · synced May 18, 2026
EUDAMED f39fa246-c470-47cd-8e72-a112f6dd50a8 61 fields · synced May 18, 2026
EUDAMED f8f1daee-f379-4c45-88c7-3d09655e9a4b 61 fields · synced May 18, 2026
EUDAMED 8f3d6c2f-1376-476c-a077-f9916504ec98 61 fields · synced May 18, 2026
EUDAMED ff3c60bb-12b1-4c3c-87d9-b1ea81c6900b 61 fields · synced May 18, 2026
EUDAMED f4ca3971-ced6-4506-8f0e-803141aaaeec 61 fields · synced May 18, 2026
EUDAMED dd20b2b3-4950-442d-9184-db81223bf46c 61 fields · synced May 19, 2026
EUDAMED eb7ec7fd-26b6-4dab-a057-b2781d400898 61 fields · synced May 19, 2026
EUDAMED 9aa2c2f2-b47b-498b-8ef9-39a7dc7ab116 61 fields · synced May 19, 2026
EUDAMED 0627e6fe-b222-4bc2-b805-bba4c8d089f6 61 fields · synced May 19, 2026
EUDAMED 7e7d42a6-7930-4294-ad98-d13b07ae4611 61 fields · synced May 19, 2026
EUDAMED dc71cf64-e490-4f4b-acbe-25fd3f638ae5 61 fields · synced May 19, 2026
EUDAMED 6c8d4e8d-67d7-4169-ab0c-a99369f6861d 61 fields · synced May 19, 2026
EUDAMED 964d35ae-aef6-4c63-b238-c28afc8d1e25 61 fields · synced May 19, 2026