Tetric Ceram HB

FDA 510(k) K010250 · Ivoclar North America, Inc.

Substantially Equivalent

510(k) numberK010250

Submission

Device name
Tetric Ceram HB
Applicant
Ivoclar North America, Inc.
Amherst, NY, US
Received
January 26, 2001
Decision date
February 28, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EBF – Material, Tooth Shade, Resin
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3690
Specialty
Dental

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K260805Dual CoreEBF · Traditional Vericom Co., Ltd.05/11/2026SE
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K010381D.Sign 30EJH · Traditional 03/06/2001SE
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Questions and answers

When was Tetric Ceram HB cleared by the FDA?

Tetric Ceram HB (K010250) received a 510(k) decision of Substantially Equivalent on February 28, 2001, 33 days after the submission was received.

What is the product code of K010250?

The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.