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Tera Harz

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref BR-23D3-500Model Tera Harz BR-23D3-500 D3 500gRef noneModel BR-23C3-500Model BR-23B2-500Model BR-23C2-1000Model BR-23B2-1000Model BR-23A3-500Model BR-23C2-500Model BR-23D2-500Model TC-80 Series, BR-23 SeriesModel BR-23C3-1000Model BR-23A1-1000Model BR-23OM1-500Model BR-23A1-500Model BR-23B3-1000Model BR-23OM1-1000Model BR-23D2-1000Model BR-23OM3-1000Model BR-23C1-500Model BR-23A2-1000Model BR-23A2-500Model BR-23D1-500Model BR-23A3-1000Ref NONEModel TC-80DPA2

by Graphy Inc.

Identity

Trade Name
TERA HARZ EUDAMEDFDA UDI
TERA HARZ II FDA UDI
Generic Name
Dental prosthesis veneer resin FDA UDI
Device Name
TERA HARZ EUDAMED
TERA HARZ, Tera Harz EUDAMED
TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The TERA HARZ II material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ II requires a computer-aided and manufacturing (CAD/CAM) system that includes the following : scanner, design software, additive printer, and post-cure unit. FDA UDI
TERA HARZ is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The TERA HARZ material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit. FDA UDI
TERA HARZ is a monomer as a biocompatible material based on Acrylic esters indicated for manufacturing of all types of preformed crown and bridge bases in dental laboratories. Fabrication of these prostheses require a manufacturing of all laser and DLP based 3D printers. FDA UDI
TERA HARZ is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The TERA HARZ material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit FDA UDI
Model / Reference
Tera Harz BR-23D3-500 D3 500g EUDAMED
BR-23D3-500 EUDAMED
BR-23C3-1000 EUDAMEDFDA UDI
BR-23D2-1000 EUDAMEDFDA UDI
BR-23C2-1000 EUDAMEDFDA UDI
TC-80DPA2 EUDAMEDFDA UDI
BR-23A1-1000 EUDAMEDFDA UDI
BR-23OM3-1000 EUDAMEDFDA UDI
BR-23A3-1000 EUDAMEDFDA UDI
BR-23B2-1000 EUDAMEDFDA UDI
BR-23OM1-1000 EUDAMEDFDA UDI
BR-23B3-1000 EUDAMEDFDA UDI
BR-23A2-1000 EUDAMEDFDA UDI
BR-23C3-500 EUDAMED
none EUDAMED
BR-23B2-500 EUDAMED
BR-23A3-500 EUDAMED
BR-23C2-500 EUDAMED
BR-23D2-500 EUDAMED
TC-80 Series, BR-23 Series EUDAMED
BR-23OM1-500 EUDAMED
BR-23A1-500 EUDAMED
BR-23C1-500 EUDAMED
BR-23A2-500 EUDAMED
BR-23D1-500 EUDAMED
TC-80DPA1 FDA UDI
TC-80DPA3 FDA UDI
Description
TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The TERA HARZ II material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ II requires a computer-aided and manufacturing (CAD/CAM) system that includes the following : scanner, design software, additive printer, and post-cure unit. FDA UDI
TERA HARZ is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The TERA HARZ material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit. FDA UDI
TERA HARZ is a monomer as a biocompatible material based on Acrylic esters indicated for manufacturing of all types of preformed crown and bridge bases in dental laboratories. Fabrication of these prostheses require a manufacturing of all laser and DLP based 3D printers. FDA UDI
TERA HARZ is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The TERA HARZ material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit FDA UDI

Identifiers

Catalog Number
NONE FDA UDI
Primary DI / UDI-DI
88001421008260 EUDAMED
08800142100772 EUDAMEDFDA UDI
08800142100109 EUDAMEDFDA UDI
08800142100819 EUDAMEDFDA UDI
08800142100123 EUDAMEDFDA UDI
08800142100758 EUDAMEDFDA UDI
08800142100116 EUDAMEDFDA UDI
08800142100611 EUDAMEDFDA UDI
08800142100895 EUDAMEDFDA UDI
08800142100659 EUDAMEDFDA UDI
08800142100697 EUDAMEDFDA UDI
08800142100857 EUDAMEDFDA UDI
08800142100710 EUDAMEDFDA UDI
08800142100635 EUDAMEDFDA UDI
08800142100765 EUDAMED
08800142100680 EUDAMED
08800142100826 EUDAMED
08800142100642 EUDAMED
08800142100741 EUDAMED
08800142100802 EUDAMED
08800142100840 EUDAMED
08800142100604 EUDAMED
08800142100727 EUDAMED
08800142100628 EUDAMED
08800142100789 EUDAMED
Basic UDI-DI
B-88001421008260 EUDAMED
B-08800142100765 EUDAMED
B-08800142100680 EUDAMED
B-08800142100826 EUDAMED
B-08800142100758 EUDAMED
B-08800142100697 EUDAMED
B-08800142100642 EUDAMED
B-08800142100741 EUDAMED
B-08800142100802 EUDAMED
88001421TERAHARZVJ EUDAMED
B-08800142100772 EUDAMED
B-08800142100611 EUDAMED
B-08800142100840 EUDAMED
B-08800142100604 EUDAMED
B-08800142100710 EUDAMED
B-08800142100857 EUDAMED
B-08800142100819 EUDAMED
B-08800142100895 EUDAMED
B-08800142100727 EUDAMED
B-08800142100635 EUDAMED
B-08800142100628 EUDAMED
B-08800142100789 EUDAMED
B-08800142100659 EUDAMED
B-08800142100116 EUDAMED
Direct Marketing DI
08800142100109 EUDAMED
08800142100123 EUDAMED
08800142100116 EUDAMED
510(k) Number
K233502 FDA UDI
K202846 FDA UDI
FDA Product Code
EBF FDA UDI
EBI FDA UDI
EBG FDA UDI
EMDN Code
Q01020502 PRE-FORMED DENTAL CROWNS EUDAMED
Q0102050199 DENTISTRY RESINS - OTHER EUDAMED
GMDN Term
Dental prosthesis veneer resin FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
872.3690 FDA UDI
872.3760 FDA UDI
872.3770 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

Yes

EUDAMEDFDA UDI

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

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Tera Harz by Graphy Inc. — Class IIa — MDR, FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Active

FDA_510K

European Union Active

CE/MDD

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

Manufacturer

Manufacturer
Graphy Inc.
EUDAMED SRN
KR-MF-000012692
Authorised Representative
SMB EUROPE SAS FR-AR-000011981

Sources (43)

  • EUDAMED 32998b97-e014-48c7-bbde-59708f35ce04 61 fields · synced Sep 17, 2026
  • FDA UDI 560394b7-892b-47bc-83ed-583d585ae20e 36 fields · synced May 29, 2026
  • FDA UDI 9868c4d9-fd6f-4fac-9ff0-944266e8f72a 36 fields · synced May 29, 2026
  • FDA UDI 62cecff0-85b0-40c3-a47b-16b802195f4e 36 fields · synced May 30, 2026
  • FDA UDI fdb87a73-93ae-4e64-954e-cdbfffb67c1f 36 fields · synced May 30, 2026
  • FDA UDI df4bd182-9e0d-428a-a080-268e53ae0812 36 fields · synced May 30, 2026
  • FDA UDI 4b4511e6-ed25-4c04-bb6f-cf42ceaebd7c 36 fields · synced May 30, 2026
  • FDA UDI 8602fe22-d05a-4726-8611-82ca84229d66 36 fields · synced May 30, 2026
  • FDA UDI 78803e59-a71c-4075-9e6d-75357e770d79 36 fields · synced May 30, 2026
  • FDA UDI e8008523-60a6-4a0b-88a7-987c336ba50d 36 fields · synced May 30, 2026
  • FDA UDI cc8cbeed-3186-477f-ac96-3ead47191da7 35 fields · synced May 30, 2026
  • FDA UDI 7c9625df-1d51-4b7a-b0fb-ccea7f4ccacd 36 fields · synced May 30, 2026
  • FDA UDI 6dafb7c2-b87c-4a10-bacc-4abb6f15756b 36 fields · synced May 30, 2026
  • FDA UDI 7fdf58fc-3bcc-4ee6-98fb-507e50956a71 36 fields · synced May 30, 2026
  • EUDAMED 5c3ca40f-0944-4390-aa01-d1a38e18dd4a 61 fields · synced Jul 8, 2026
  • EUDAMED efe512e7-6b20-47cd-955b-28e685c76c7b 61 fields · synced Jul 9, 2026
  • EUDAMED 8af037f1-6c78-430b-ae71-1f76ab40e352 61 fields · synced Jul 9, 2026
  • EUDAMED d4b63547-d5e2-4d7f-80ea-9b1a0b38d2bf 61 fields · synced Jul 9, 2026
  • EUDAMED 0b4b742a-6b80-4e3d-aa1f-214fb54372c5 61 fields · synced Jul 9, 2026
  • EUDAMED dd830999-36ce-4b94-b63c-bfa39d5906e7 61 fields · synced Jul 10, 2026
  • EUDAMED 0b278637-bd88-4637-9c34-c5a1b84231c0 61 fields · synced Jul 12, 2026
  • EUDAMED b18e490b-475f-41cb-82d6-ab9a2c2d4b9b 61 fields · synced Jul 15, 2026
  • EUDAMED 2516d801-e2d5-4ec2-a238-d21b84dbf655-1 61 fields · synced Jul 15, 2026
  • EUDAMED 2516d801-e2d5-4ec2-a238-d21b84dbf655-2 61 fields · synced Jul 15, 2026
  • EUDAMED fc3f0d48-653e-47ac-9243-f101e03686c4 61 fields · synced Jul 18, 2026
  • EUDAMED be56e4f4-0a32-412f-bd10-31755ffa52a8 61 fields · synced Jul 19, 2026
  • EUDAMED fdd9a9e1-e365-4f95-ba4a-b0925102efd1 61 fields · synced Jul 20, 2026
  • EUDAMED 62b2e470-4be6-452a-baf3-131340d2f2c1 61 fields · synced Jul 23, 2026
  • EUDAMED 8d942ba1-2798-488c-b916-44eed85794ee-1 61 fields · synced Jul 25, 2026
  • EUDAMED 8d942ba1-2798-488c-b916-44eed85794ee-2 61 fields · synced Jul 25, 2026
  • EUDAMED 1af62c71-3903-4a75-a0d0-4847181a1208 61 fields · synced Jul 26, 2026
  • EUDAMED d2d54eab-23c1-4991-ae45-bfb866e10788 61 fields · synced Jul 26, 2026
  • EUDAMED 137dbf5c-8aa2-4275-a689-2e16dbc61bf2 61 fields · synced Jul 26, 2026
  • EUDAMED aaa452a3-5277-4af3-bca5-1faf3526df77 61 fields · synced Jul 27, 2026
  • EUDAMED 90005da3-5e1f-4cb1-98e5-816d5c4dbef4 61 fields · synced Jul 27, 2026
  • EUDAMED 84896588-1485-427a-8321-1818b491242e 61 fields · synced Jul 28, 2026
  • EUDAMED 2ec9c6ba-3db3-4b5f-affe-b1d9d36d1c04 61 fields · synced Jul 30, 2026
  • EUDAMED c6222cbd-de93-4f3b-91f5-21de06e16fc7 61 fields · synced Jul 31, 2026
  • EUDAMED 4f469d06-9c08-4514-ba5e-dc353f5e34cb-1 61 fields · synced Jul 31, 2026
  • EUDAMED 4f469d06-9c08-4514-ba5e-dc353f5e34cb-2 61 fields · synced Jul 31, 2026
  • EUDAMED 95df91a6-2d06-4fb5-a67e-ab9b0897a9db 61 fields · synced Aug 3, 2026
  • EUDAMED a365cfa0-c8cc-4d7f-87eb-9d0579055c27 61 fields · synced Sep 17, 2026
  • FDA 510(k) K202846 1 fields · synced May 18, 2026