Tera Harz Ii

FDA UDI

Class II (US FDA UDI)

by Graphy Inc.

Identity

Trade Name: TERA HARZ II FDA UDI
Generic Name: Dental prosthesis veneer resin FDA UDI
Device Name: 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
Model / Reference: BR-23D3-1000 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

Identifiers

Catalog Number: NONE FDA UDI
Primary DI / UDI-DI: 08800142100833 FDA UDI
510(k) Number: K233502 FDA UDI
FDA Product Code: EBF FDA UDI
EBG FDA UDI
GMDN Term: Dental prosthesis veneer resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3690 FDA UDI
872.3770 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental prosthesis veneer resin

Tera Harz Ii by Graphy Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental prosthesis veneer resin.

Defend — Young Innovations, Inc. · Class II
Ceramage — SHOFU DENTAL CORP. · Class II
CERAMAGE — SHOFU DENTAL CORP. · Class II
Ceramill — Vertex-Dental B.V. · Class I
Signum composite flow — Kulzer, Inc. · Class II
Solidex — SHOFU DENTAL CORP. · Class II
Universal Opaque — SHOFU DENTAL CORP. · Class II
Universal Opaque — SHOFU DENTAL CORP. · Class II

Cleared under the same submission

K233502 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Graphy Inc.

Sources (1)

FDA UDI 314de827-fbed-4c3b-b19a-1c52cd107931 36 fields · synced Jun 6, 2026