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Pre-Sintered Zirconia Coloring Liquid

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref 3M3 20mlRef 2M3 20ml510(k) K232682Ref C3 50mlRef 0M3 20mlRef 5M3 20mlRef D4 50mlRef 2L2.5 50mlRef 0M2 20mlRef BL3 50mlRef B4 20mlRef 4M1 50mlRef 4L1.5 50mlRef C2 20mlRef 3L1.5 50mlRef 3R1.5 20mlRef O3 50mlRef TO2 50mlRef 3M1 50mlRef BL2 20mlRef TO4 20mlRef 3M3 50mlRef P3 20mlRef 2M3 50mlRef 3R2.5 50mlRef 3M2 50mlRef BL4 50mlRef 4R2.5 20mlRef 2R2.5 20mlRef TO3 20mlRef A1 20mlRef BL3 20mlRef 2L1.5 50mlRef 1M1 20mlRef C2 50mlRef 2M1 50mlRef D3 20mlRef 2M2 20mlRef 0M1 20mlRef G2 50mlRef P2 20mlRef 2M2 50mlRef TO4 50mlRef B1 50mlRef 3M1 20mlRef G1 20mlRef C1 50mlRef 0M1 50mlRef B1 20mlRef 4L2.5 20mlRef 4R2.5 50mlRef P2 50mlRef A4 50mlRef P3 50mlRef TO3 50mlRef D2 20mlRef 4R1.5 20mlRef D3 50mlRef O3 20mlRef 5M2 50mlRef 4L1.5 20mlRef G3 50mlRef 4M1 20mlRef B2 20mlRef TO1 50mlRef A3.5 20mlRef 2L2.5 20mlRef 5M3 50mlRef P1 20mlRef C3 20mlRef 3L1.5 20mlRef BL1 50ml

by Chengdu Besmile Medical Technology Co., Ltd.

Identity

Trade Name
Pre-Sintered Zirconia Coloring Liquid EUDAMEDFDA UDI
Generic Name
Dental appliance fabrication material, ceramic FDA UDI
Device Name
Pre-Sintered Zirconia Coloring Liquid EUDAMED
Model / Reference
3M3 20ml EUDAMEDFDA UDI
2M3 20ml EUDAMEDFDA UDI
C3 50ml EUDAMED
0M3 20ml EUDAMEDFDA UDI
5M3 20ml EUDAMEDFDA UDI
D4 50ml EUDAMEDFDA UDI
2L2.5 50ml EUDAMEDFDA UDI
0M2 20ml EUDAMEDFDA UDI
BL3 50ml EUDAMEDFDA UDI
B4 20ml EUDAMED
4M1 50ml EUDAMEDFDA UDI
4L1.5 50ml EUDAMEDFDA UDI
C2 20ml EUDAMED
3L1.5 50ml EUDAMEDFDA UDI
3R1.5 20ml EUDAMEDFDA UDI
O3 50ml EUDAMEDFDA UDI
TO2 50ml EUDAMEDFDA UDI
3M1 50ml EUDAMEDFDA UDI
BL2 20ml EUDAMEDFDA UDI
TO4 20ml EUDAMEDFDA UDI
3M3 50ml EUDAMEDFDA UDI
P3 20ml EUDAMEDFDA UDI
2M3 50ml EUDAMEDFDA UDI
3R2.5 50ml EUDAMEDFDA UDI
3M2 50ml EUDAMEDFDA UDI
BL4 50ml EUDAMEDFDA UDI
4R2.5 20ml EUDAMEDFDA UDI
2R2.5 20ml EUDAMEDFDA UDI
TO3 20ml EUDAMEDFDA UDI
A1 20ml EUDAMED
BL3 20ml EUDAMEDFDA UDI
2L1.5 50ml EUDAMEDFDA UDI
1M1 20ml EUDAMEDFDA UDI
C2 50ml EUDAMED
2M1 50ml EUDAMEDFDA UDI
D3 20ml EUDAMED
2M2 20ml EUDAMEDFDA UDI
0M1 20ml EUDAMEDFDA UDI
G2 50ml EUDAMEDFDA UDI
P2 20ml EUDAMEDFDA UDI
2M2 50ml EUDAMEDFDA UDI
TO4 50ml EUDAMEDFDA UDI
B1 50ml EUDAMED
3M1 20ml EUDAMEDFDA UDI
G1 20ml EUDAMEDFDA UDI
C1 50ml EUDAMED
0M1 50ml EUDAMEDFDA UDI
B1 20ml EUDAMED
4L2.5 20ml EUDAMEDFDA UDI
4R2.5 50ml EUDAMEDFDA UDI
P2 50ml EUDAMEDFDA UDI
A4 50ml EUDAMED
P3 50ml EUDAMEDFDA UDI
TO3 50ml EUDAMEDFDA UDI
D2 20ml EUDAMED
4R1.5 20ml EUDAMEDFDA UDI
D3 50ml EUDAMED
O3 20ml EUDAMEDFDA UDI
5M2 50ml EUDAMEDFDA UDI
4L1.5 20ml EUDAMEDFDA UDI
G3 50ml EUDAMEDFDA UDI
4M1 20ml EUDAMEDFDA UDI
B2 20ml EUDAMED
TO1 50ml EUDAMEDFDA UDI
A3.5 20ml EUDAMED
2L2.5 20ml EUDAMEDFDA UDI
5M3 50ml EUDAMEDFDA UDI
P1 20ml EUDAMEDFDA UDI
C3 20ml EUDAMED
3L1.5 20ml EUDAMEDFDA UDI
BL1 50ml EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
06932195328130 EUDAMEDFDA UDI
06932195328062 EUDAMEDFDA UDI
06932195322978 EUDAMED
06932195341368 EUDAMEDFDA UDI
06932195328253 EUDAMEDFDA UDI
06932195323012 EUDAMEDFDA UDI
06932195323050 EUDAMEDFDA UDI
06932195341320 EUDAMEDFDA UDI
06932195341504 EUDAMEDFDA UDI
06932195327928 EUDAMED
06932195323203 EUDAMEDFDA UDI
06932195323180 EUDAMEDFDA UDI
06932195327942 EUDAMED
06932195323111 EUDAMEDFDA UDI
06932195328147 EUDAMEDFDA UDI
06932195363728 EUDAMEDFDA UDI
06932195327829 EUDAMEDFDA UDI
06932195323135 EUDAMEDFDA UDI
06932195341443 EUDAMEDFDA UDI
06932195323371 EUDAMEDFDA UDI
06932195323159 EUDAMEDFDA UDI
06932195323401 EUDAMEDFDA UDI
06932195323081 EUDAMEDFDA UDI
06932195323173 EUDAMEDFDA UDI
06932195323142 EUDAMEDFDA UDI
06932195341542 EUDAMEDFDA UDI
06932195328222 EUDAMEDFDA UDI
06932195328086 EUDAMEDFDA UDI
06932195323364 EUDAMEDFDA UDI
06932195327843 EUDAMED
06932195341481 EUDAMEDFDA UDI
06932195323043 EUDAMEDFDA UDI
06932195328000 EUDAMEDFDA UDI
06932195322961 EUDAMED
06932195323067 EUDAMEDFDA UDI
06932195327980 EUDAMED
06932195328055 EUDAMEDFDA UDI
06932195341283 EUDAMEDFDA UDI
06932195327744 EUDAMEDFDA UDI
06932195323395 EUDAMEDFDA UDI
06932195323074 EUDAMEDFDA UDI
06932195341276 EUDAMEDFDA UDI
06932195322916 EUDAMED
06932195328116 EUDAMEDFDA UDI
06932195323319 EUDAMEDFDA UDI
06932195322954 EUDAMED
06932195341306 EUDAMEDFDA UDI
06932195327898 EUDAMED
06932195328178 EUDAMEDFDA UDI
06932195323241 EUDAMEDFDA UDI
06932195327775 EUDAMEDFDA UDI
06932195322909 EUDAMED
06932195327782 EUDAMEDFDA UDI
06932195327836 EUDAMEDFDA UDI
06932195327973 EUDAMED
06932195328215 EUDAMEDFDA UDI
06932195323005 EUDAMED
06932195323432 EUDAMEDFDA UDI
06932195323265 EUDAMEDFDA UDI
06932195328161 EUDAMEDFDA UDI
06932195327751 EUDAMEDFDA UDI
06932195328185 EUDAMEDFDA UDI
06932195327904 EUDAMED
06932195327812 EUDAMEDFDA UDI
06932195327874 EUDAMED
06932195328031 EUDAMEDFDA UDI
06932195323272 EUDAMEDFDA UDI
06932195323388 EUDAMEDFDA UDI
06932195327959 EUDAMED
06932195328093 EUDAMEDFDA UDI
06932195341429 EUDAMEDFDA UDI
Basic UDI-DI
697558188RSY0708C6 EUDAMED
510(k) Number
K232682 FDA UDI
FDA Product Code
EIH FDA UDI
EMDN Code
Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
GMDN Term
Dental appliance fabrication material, ceramic FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
872.6660 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDIEUDAMED

Reusable

No

EUDAMED

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

No

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDIFDA UDI

Manufacturing Date

Yes

FDA UDIFDA UDI

Pre-Sintered Zirconia Coloring Liquid by Chengdu Besmile Medical Technology Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)

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 (199)

  • EUDAMED 67e5714b-1ac5-4032-be38-a74f78a68ed0 61 fields · synced Sep 18, 2026
  • EUDAMED a4fd530e-509b-4dcb-9af3-74c0c2c56479 85 fields · synced May 11, 2026
  • EUDAMED 03df5b9e-d04f-4e1b-a7a5-62c9e80985bf 61 fields · synced May 11, 2026
  • EUDAMED 19ded6b8-9db2-4e4d-9986-f6bd2d499cb5 61 fields · synced May 11, 2026
  • EUDAMED 4fc2c542-d431-4e6f-a095-a8b8c837e53c 61 fields · synced May 16, 2026
  • EUDAMED 685a9009-c061-4388-9eb7-67d6815042c4 61 fields · synced May 16, 2026
  • EUDAMED ce4ea698-b4dd-4225-8123-de1b05e7f7d1 61 fields · synced May 16, 2026
  • EUDAMED ce5c3a55-3f0f-4396-882b-86c4fc92caa6 61 fields · synced May 16, 2026
  • EUDAMED 760a315d-3d24-428d-b4d0-0228134fde55 61 fields · synced May 16, 2026
  • EUDAMED 5de86df2-f9bb-45ff-8778-bfe72d19692a 61 fields · synced May 16, 2026
  • EUDAMED 094b5b32-2ef5-431e-ae0b-0fd5fa5fe9b3 61 fields · synced May 16, 2026
  • EUDAMED 2ee5ef0a-aa7c-402c-a33c-96482c5eff67 61 fields · synced May 16, 2026
  • EUDAMED 7205a75c-32cc-439b-8484-b34309e07b34 61 fields · synced May 16, 2026
  • EUDAMED 8dd0f83c-abf1-4c89-bc3e-e937ac7839d5 61 fields · synced May 16, 2026
  • EUDAMED d0c0cede-421c-4abc-be91-b212adfe4659 61 fields · synced May 17, 2026
  • EUDAMED 9282b3eb-e9ab-4475-82a7-990c2f280fed 61 fields · synced May 17, 2026
  • EUDAMED 2fad900d-e396-4de8-b2cc-8e21ffe488a5 61 fields · synced May 17, 2026
  • EUDAMED a3769543-06c7-4101-85eb-d79dff2c44d5 61 fields · synced May 17, 2026
  • EUDAMED 93a684bd-5c46-4da0-b5c4-8e1e989c5e65 61 fields · synced May 17, 2026
  • EUDAMED 747b472c-3c49-44df-94ac-693bae548a33 61 fields · synced May 17, 2026
  • EUDAMED 6c963f05-8293-4802-ba4b-d20483d0dad5 61 fields · synced May 17, 2026
  • EUDAMED 3d3ddfa9-c017-4f17-b1b7-3550ec5710dc 61 fields · synced May 17, 2026
  • EUDAMED 9d9b9c13-4e40-4b98-a47e-fdb5a40a63ed 61 fields · synced May 17, 2026
  • EUDAMED 13b55754-18d4-4093-be6b-271ea8642439 61 fields · synced May 17, 2026
  • EUDAMED b2f83b58-8fea-48f5-b710-4506a83fdfcf 61 fields · synced May 17, 2026
  • EUDAMED c7f27507-1cc5-41bb-a25d-8abc728500a8 61 fields · synced May 17, 2026
  • EUDAMED 8e925aae-8028-4c45-a01e-c51d4881f2f1 61 fields · synced May 17, 2026
  • EUDAMED 5751f38c-4c5a-4cc9-b446-f3bc5c86d897 61 fields · synced May 17, 2026
  • EUDAMED 69a2180d-4112-4e75-949c-48b9760aab5b 61 fields · synced May 17, 2026
  • EUDAMED a64742ae-e887-4bc2-a5c7-b299dd1b5a83 61 fields · synced May 17, 2026
  • EUDAMED e1eba821-2bbd-49e8-acec-f5b2388815d2 61 fields · synced May 17, 2026
  • EUDAMED 0ce2a08e-39c9-4091-bea6-a22b34c152dc 61 fields · synced May 17, 2026
  • EUDAMED 847c630b-9f3b-4074-a066-48027bdcad1c 61 fields · synced May 17, 2026
  • EUDAMED 9ead3af8-a125-4f48-ba75-3fbe11a314fb 61 fields · synced May 17, 2026
  • EUDAMED c78c2494-af07-4ee9-b7cc-b01039d0bf42 61 fields · synced May 17, 2026
  • EUDAMED 2caab535-bb3a-4359-afda-0569e188ff70 61 fields · synced May 17, 2026
  • EUDAMED 3975c347-f4a3-4175-aefb-a4cdc073ce4d 61 fields · synced May 17, 2026
  • EUDAMED 200002a2-8c0c-4872-bd6e-40b40127f026 61 fields · synced May 17, 2026
  • EUDAMED 6ac0cc6d-3b2d-45fc-8bec-e48946533f03 61 fields · synced May 17, 2026
  • EUDAMED 31d7dbfc-df51-4342-b77f-5d2a0310fe56 61 fields · synced May 18, 2026
  • EUDAMED 2308a955-1c5c-4d53-8ae0-4920a044d1e5 61 fields · synced May 18, 2026
  • EUDAMED 8628286c-2cf0-4708-bdbb-8031a2e88f0e 61 fields · synced May 18, 2026
  • EUDAMED fa5c7315-1c31-4210-b1e7-f7dc02b1ecea 61 fields · synced May 18, 2026
  • EUDAMED 398d5a60-f1e8-466d-9620-1aeb4abafce3 61 fields · synced May 18, 2026
  • EUDAMED 749a04fe-c448-4890-8e6f-ca30be9aed4b 61 fields · synced May 18, 2026
  • EUDAMED 98ce40d0-8b2e-41b9-8dc3-c833ffbd7a78 61 fields · synced May 18, 2026
  • EUDAMED 9b3bc368-6623-4b1e-9de9-8a38f85283bc 61 fields · synced May 18, 2026
  • EUDAMED afbfb7ff-9676-470b-a8e9-a2baf096a686 61 fields · synced May 18, 2026
  • EUDAMED 4f52444a-c300-44da-a249-215d04eb0b6d 61 fields · synced May 18, 2026
  • EUDAMED 38f8fe85-d950-40d9-87ed-1815451c22ac 61 fields · synced May 18, 2026
  • EUDAMED 2baccdb6-5ab7-41bb-a34c-135b230e8170 61 fields · synced May 18, 2026
  • EUDAMED bbcb1c63-1e51-46ec-8bea-c5bd0b782727 61 fields · synced May 18, 2026
  • EUDAMED 9f6b0399-1b54-4229-b6fc-d67d4db4af5b 61 fields · synced May 18, 2026
  • EUDAMED cbde6679-dab4-4001-a9b9-ce8c0a616b96 61 fields · synced May 18, 2026
  • EUDAMED acca2c1f-2502-4165-80cd-6b16d01da7e7 61 fields · synced May 18, 2026
  • EUDAMED 22ff42d7-2521-471c-9929-325f5f51ef50 61 fields · synced May 18, 2026
  • EUDAMED 2f7b43cb-be55-487d-a96c-ec9d539c3d67 61 fields · synced May 18, 2026
  • EUDAMED 86a72b1e-8ec0-4398-96a1-c0bb8620192b 61 fields · synced May 18, 2026
  • EUDAMED 657c1434-772a-473b-8104-cb6d1a412af3 61 fields · synced May 18, 2026
  • EUDAMED cfabd6e7-dee7-4c20-9118-c9d4bcc15ed3 61 fields · synced May 18, 2026
  • EUDAMED 4a9dc55f-2513-41b4-be66-e4082cecab86 61 fields · synced May 18, 2026
  • EUDAMED 9d4ff8b2-9d8e-42c2-8300-1a7566db755a 61 fields · synced May 18, 2026
  • EUDAMED f7ce50c1-1254-456c-a5f0-e140ad9fcc3e 61 fields · synced May 18, 2026
  • EUDAMED 8246b279-d0d6-41a9-a5eb-29bb18937b35 61 fields · synced May 18, 2026
  • EUDAMED 949da7a0-935e-48e5-bd0b-28e3082b6b74 61 fields · synced May 18, 2026
  • EUDAMED be1ac6a9-ad6c-4781-bd37-5bdfd451280b 61 fields · synced May 18, 2026
  • EUDAMED a30824f0-435c-4d77-9718-7b7c1d671372 61 fields · synced May 18, 2026
  • EUDAMED 25ae2e3a-08bd-431f-99d3-1e6680ea641d 61 fields · synced May 19, 2026
  • EUDAMED 860137bd-1754-43bf-bb44-278124ba93ac 61 fields · synced May 19, 2026
  • EUDAMED fd7f0aea-861f-42c5-a10d-92322a280312 61 fields · synced May 19, 2026
  • EUDAMED d46214b9-d33a-4319-ba19-a63a284635b3 61 fields · synced May 19, 2026
  • FDA UDI 8894f666-8a1d-4707-a818-9ff092f60b48 33 fields · synced May 26, 2026
  • FDA UDI c8413e9f-befa-44c3-9a61-8b00a8ff304e 33 fields · synced May 27, 2026
  • FDA UDI cf85b2cf-03b3-4c1a-a401-0184f24c567e 33 fields · synced May 27, 2026
  • FDA UDI d4864ea3-55d8-4d46-a299-84ada287d706 33 fields · synced May 27, 2026
  • FDA UDI 761abc46-8697-4c55-99b1-ce845efc71a9 33 fields · synced May 29, 2026
  • FDA UDI 60c1cbcb-4b5f-4a57-9476-41540f4fcb95 33 fields · synced May 29, 2026
  • FDA UDI cc2d5e21-a0a3-417b-87a2-59c5d8b310a8 33 fields · synced May 29, 2026
  • FDA UDI 1bbb949c-73e5-4e60-820a-0bbf73b64ab1 33 fields · synced May 29, 2026
  • FDA UDI 4ac3e244-8859-4ef1-b277-5ac9723dec8c 33 fields · synced May 29, 2026
  • FDA UDI 4be04fd0-599f-4491-8c7c-d8972ac2126a 33 fields · synced May 29, 2026
  • FDA UDI 039b5de9-b644-42e5-ac04-d8e013910f16 33 fields · synced May 29, 2026
  • FDA UDI c4338ad4-ea37-43af-8448-cd3bdd8341d0 33 fields · synced May 30, 2026
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  • FDA UDI a8216930-f3d7-46ee-a2a6-1159b4c99f66 33 fields · synced May 30, 2026
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  • EUDAMED c595b97a-fd4f-4add-8e31-7b9650d9f627 61 fields · synced Jun 20, 2026
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  • EUDAMED 5a309975-2aba-451a-be44-22d9b885e127 61 fields · synced Sep 18, 2026
  • FDA 510(k) K232682 1 fields · synced May 18, 2026