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Dental Glass Ceramics

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref HT B4 18.5×16.9×12.5Ref HT A3.5 40×15×14Ref LT D2 18.5×17.9×12.5Ref LT D3 40×15×14510(k) K232673Ref LT C2 18.5×16.9×12.5Ref LT B1 18.5×14.9×12.5Ref HT 0M3 18.5×17.9×12.5Ref HT A4 12.5×11Ref LT A1 18.5×17.9×12.5Ref HT C4 18.5×14.9×12.5Ref HT A1 18.5×17.9×12.5Ref LT D4 12.5×13Ref HT D3 12.5×13Ref HT C2 12.5×17Ref HT D2 18.5×16.9×12.5Ref LT 0M3 12.5×13Ref LT A4 18.5×14.9×12.5Ref HT C1 18.5×14.9×12.5Ref HT C1 12.5×15Ref HT B4 18.5×17.9×12.5Ref LT 0M2 12.5×15Ref HT C2 12.5×15Ref LT 0M1 12.5×13Ref HT B1 18.5×17.9×12.5Ref HT 0M3 18.5×14.9×12.5Ref LT A4 12.5×17Ref HT C3 12.5×11Ref HT B3 18.5×14.9×12.5Ref LT C3 18.5×17.9×12.5Ref HT A4 18.5×16.9×12.5Ref HT B2 18.5×16.9×12.5Ref HT C3 12.5×13Ref HT A4 40×15×14Ref LT B2 12.5×13Ref LT A3 18.5×14.9×12.5Ref LT D4 12.5×11Ref HT B4 12.5×13Ref HT A3.5 18.5×14.9×12.5Ref LT A3.5 12.5×17Ref LT C3 40×15×14Ref LT 0M2 18.5×16.9×12.5Ref LT B4 18.5×16.9×12.5Ref LT A3.5 18.5×16.9×12.5Ref HT 0M3 12.5×15Ref LT B2 18.5×16.9×12.5Ref HT D2 18.5×14.9×12.5Ref HT D4 12.5×17Ref HT B3 18.5×17.9×12.5Ref HT C2 12.5×11Ref HT A2 12.5×11Ref HT A4 12.5×15

by Chengdu Besmile Medical Technology Co., Ltd.

Identity

Trade Name
Dental Glass Ceramics EUDAMED
Device Name
Dental Glass Ceramics EUDAMED
Model / Reference
HT B4 18.5×16.9×12.5 EUDAMED
HT A3.5 40×15×14 EUDAMED
LT D2 18.5×17.9×12.5 EUDAMED
LT D3 40×15×14 EUDAMED
LT C2 18.5×16.9×12.5 EUDAMED
LT B1 18.5×14.9×12.5 EUDAMED
HT 0M3 18.5×17.9×12.5 EUDAMED
HT A4 12.5×11 EUDAMED
LT A1 18.5×17.9×12.5 EUDAMED
HT C4 18.5×14.9×12.5 EUDAMED
HT A1 18.5×17.9×12.5 EUDAMED
LT D4 12.5×13 EUDAMED
HT D3 12.5×13 EUDAMED
HT C2 12.5×17 EUDAMED
HT D2 18.5×16.9×12.5 EUDAMED
LT 0M3 12.5×13 EUDAMED
LT A4 18.5×14.9×12.5 EUDAMED
HT C1 18.5×14.9×12.5 EUDAMED
HT C1 12.5×15 EUDAMED
HT B4 18.5×17.9×12.5 EUDAMED
LT 0M2 12.5×15 EUDAMED
HT C2 12.5×15 EUDAMED
LT 0M1 12.5×13 EUDAMED
HT B1 18.5×17.9×12.5 EUDAMED
HT 0M3 18.5×14.9×12.5 EUDAMED
LT A4 12.5×17 EUDAMED
HT C3 12.5×11 EUDAMED
HT B3 18.5×14.9×12.5 EUDAMED
LT C3 18.5×17.9×12.5 EUDAMED
HT A4 18.5×16.9×12.5 EUDAMED
HT B2 18.5×16.9×12.5 EUDAMED
HT C3 12.5×13 EUDAMED
HT A4 40×15×14 EUDAMED
LT B2 12.5×13 EUDAMED
LT A3 18.5×14.9×12.5 EUDAMED
LT D4 12.5×11 EUDAMED
HT B4 12.5×13 EUDAMED
HT A3.5 18.5×14.9×12.5 EUDAMED
LT A3.5 12.5×17 EUDAMED
LT C3 40×15×14 EUDAMED
LT 0M2 18.5×16.9×12.5 EUDAMED
LT B4 18.5×16.9×12.5 EUDAMED
LT A3.5 18.5×16.9×12.5 EUDAMED
HT 0M3 12.5×15 EUDAMED
LT B2 18.5×16.9×12.5 EUDAMED
HT D2 18.5×14.9×12.5 EUDAMED
HT D4 12.5×17 EUDAMED
HT B3 18.5×17.9×12.5 EUDAMED
HT C2 12.5×11 EUDAMED
HT A2 12.5×11 EUDAMED
HT A4 12.5×15 EUDAMED

Identifiers

Primary DI / UDI-DI
06932195331390 EUDAMED
06932195331062 EUDAMED
06932195333080 EUDAMED
06932195333165 EUDAMED
06932195332861 EUDAMED
06932195323784 EUDAMED
06932195330775 EUDAMED
06932195331109 EUDAMED
06932195332175 EUDAMED
06932195323562 EUDAMED
06932195330843 EUDAMED
06932195333189 EUDAMED
06932195331789 EUDAMED
06932195331529 EUDAMED
06932195331741 EUDAMED
06932195332069 EUDAMED
06932195323777 EUDAMED
06932195323531 EUDAMED
06932195331444 EUDAMED
06932195331406 EUDAMED
06932195332007 EUDAMED
06932195331512 EUDAMED
06932195331925 EUDAMED
06932195331192 EUDAMED
06932195323623 EUDAMED
06932195332465 EUDAMED
06932195331567 EUDAMED
06932195323517 EUDAMED
06932195332946 EUDAMED
06932195331079 EUDAMED
06932195331253 EUDAMED
06932195331574 EUDAMED
06932195331093 EUDAMED
06932195332557 EUDAMED
06932195323753 EUDAMED
06932195333172 EUDAMED
06932195331369 EUDAMED
06932195323470 EUDAMED
06932195332366 EUDAMED
06932195332953 EUDAMED
06932195332021 EUDAMED
06932195332724 EUDAMED
06932195332373 EUDAMED
06932195330744 EUDAMED
06932195332588 EUDAMED
06932195323579 EUDAMED
06932195331871 EUDAMED
06932195331338 EUDAMED
06932195331499 EUDAMED
06932195330867 EUDAMED
06932195331123 EUDAMED
Basic UDI-DI
697558188BLTC0708CN EUDAMED
69321953BLTC0323RG EUDAMED
EMDN Code
Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

Yes

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

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

Dental Glass Ceramics by Chengdu Besmile Medical Technology Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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

Manufacturer

Manufacturer
Chengdu Besmile Medical Technology Co., Ltd.
EUDAMED SRN
CN-MF-000025929
Authorised Representative
MedPath GmbH DE-AR-000000087

Sources (52)

  • EUDAMED 18521661-6254-4066-8367-3ceb5edfb997 61 fields · synced Sep 18, 2026
  • EUDAMED 2beeeebd-7389-4959-94d3-c7b1984cca4d 61 fields · synced May 11, 2026
  • EUDAMED 380935ad-4638-4954-a436-d9b4f1fcedf4 61 fields · synced May 11, 2026
  • EUDAMED 42d4a2fb-2826-4b96-819d-2d2416a89311 85 fields · synced May 11, 2026
  • EUDAMED 4b3f8fb1-3398-48f9-9377-eb6f1ec3a513 61 fields · synced May 11, 2026
  • EUDAMED 4f2a625f-e0fc-4dc0-a1ee-0e3456c23117 61 fields · synced May 11, 2026
  • EUDAMED ad593437-ad21-46be-abda-4abbb497d420 61 fields · synced May 11, 2026
  • EUDAMED b935435b-7a51-4f16-a263-fb1026d958b8 61 fields · synced May 11, 2026
  • EUDAMED c27cd202-0205-495c-8ece-edc8ad67565c 61 fields · synced May 11, 2026
  • EUDAMED c894a28c-0403-47c2-a528-dd36b9a1c440 61 fields · synced May 11, 2026
  • EUDAMED dc2b847f-f724-45f4-b6e5-88f74bfb5e23 61 fields · synced May 11, 2026
  • EUDAMED efc77324-ada3-4738-bbb7-750e08dadb0f 61 fields · synced May 11, 2026
  • EUDAMED 06aca5e2-5660-4bb7-bc55-bd88da2a7929 61 fields · synced May 11, 2026
  • EUDAMED 0fc49614-1ed6-449c-815a-ffb0f587ff2d 61 fields · synced May 11, 2026
  • EUDAMED 1021165e-ef69-4f26-8199-bbb895bc3414 61 fields · synced May 11, 2026
  • EUDAMED cd0470f3-fa5a-4aa7-ad97-489d6b91cd2c 61 fields · synced May 16, 2026
  • EUDAMED 535e4a16-0520-4a43-81f6-04129dd13f8d 61 fields · synced May 16, 2026
  • EUDAMED a73af5be-1ce6-49f7-bca6-d3a44578cc1f 61 fields · synced May 16, 2026
  • EUDAMED ec8c64d1-5afe-4cbe-a965-ab0191e71187 61 fields · synced May 16, 2026
  • EUDAMED ee1dfd65-8c0b-45a4-9f9e-bc5643df8736 61 fields · synced May 16, 2026
  • EUDAMED d00734dc-efc7-4e30-9d90-da4ac7182c81 61 fields · synced May 16, 2026
  • EUDAMED 9a6e596f-1012-44c7-9951-271a431fcf20 61 fields · synced May 16, 2026
  • EUDAMED c7a3c237-156f-482d-b3dd-8afcb1c84685 61 fields · synced May 16, 2026
  • EUDAMED 875050eb-9d46-4402-9dac-7f7f3b5e7b65 61 fields · synced May 16, 2026
  • EUDAMED 77dd8ea3-f209-434c-97df-173395a98ebb 61 fields · synced May 16, 2026
  • EUDAMED 76a394b8-a162-49b9-8840-d9f63e97f023 61 fields · synced May 16, 2026
  • EUDAMED af70a074-0e53-4452-8609-f75c23276fdc 61 fields · synced May 16, 2026
  • EUDAMED 744ca4a3-fc65-421c-9e9f-9369a6485c78 61 fields · synced May 16, 2026
  • EUDAMED 63d6adf9-1b52-48d7-b24a-61c1dd437da8 61 fields · synced May 16, 2026
  • EUDAMED 22499218-926c-42bc-9352-ed113a7a911b 61 fields · synced May 16, 2026
  • EUDAMED 01a268da-468b-4c3e-8d69-d8826182e208 61 fields · synced May 16, 2026
  • EUDAMED 53bb22cc-a007-4873-a758-e846c85ee227 61 fields · synced May 16, 2026
  • EUDAMED 79b2c22e-e4e2-4e4c-97b2-5312d9496959 61 fields · synced May 16, 2026
  • EUDAMED dc639c83-5556-45ae-8628-55e6247b1713 61 fields · synced May 16, 2026
  • EUDAMED 4ca96ad1-b8e6-4616-9ba2-6723bf4573f5 61 fields · synced May 16, 2026
  • EUDAMED c6e94752-c13b-4678-8d52-72b8d505e150 61 fields · synced May 16, 2026
  • EUDAMED 37686948-aa72-4140-b0f1-e1cc91b18b53 61 fields · synced May 16, 2026
  • EUDAMED 48209425-fa5e-4368-bea2-ca3304f9bf7e 61 fields · synced May 16, 2026
  • EUDAMED c2c36765-9478-41a6-9cdc-b09d3e48f2c3 61 fields · synced May 16, 2026
  • EUDAMED 892739d7-ed94-40c6-899b-b6b55023d4d6 61 fields · synced May 16, 2026
  • EUDAMED c48297f6-fe3e-4229-8398-25fef93ff028 61 fields · synced May 16, 2026
  • EUDAMED 88dd57c5-3d51-4036-a465-e5b6669d0b6b 61 fields · synced May 17, 2026
  • EUDAMED af18818c-4951-4987-b91c-b52d216291a2 61 fields · synced May 17, 2026
  • EUDAMED 9c928298-ec8d-46ea-94ba-270a10dc845f 61 fields · synced May 17, 2026
  • EUDAMED ac3953a0-634f-4d62-9545-d5e51dc6c381 61 fields · synced May 17, 2026
  • EUDAMED 1bc02163-6ecc-4520-93aa-912b72ce15ee 61 fields · synced May 17, 2026
  • EUDAMED 88c6568e-061d-4516-85b3-dbeff5e9b858 61 fields · synced May 17, 2026
  • EUDAMED 24598e21-f8d4-4349-ada7-375269e3032d 61 fields · synced May 17, 2026
  • EUDAMED a51301e4-44f4-49c9-94a3-de477daeafc7 61 fields · synced May 17, 2026
  • EUDAMED 7321228b-675f-44eb-846e-735958819411 61 fields · synced May 17, 2026
  • EUDAMED 01b9868f-770e-472f-bef1-c271ac62825c 61 fields · synced May 17, 2026
  • FDA 510(k) K232673 1 fields · synced May 18, 2026