Belleglass Point 4

FDA 510(k) K030646 · Kerr Dental Materials Center

Substantially Equivalent

510(k) numberK030646

Submission

Device name
Belleglass Point 4
Applicant
Kerr Dental Materials Center
Orange, CA, US
Received
February 28, 2003
Decision date
May 6, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EBD – Coating, Filling Material, Resin
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3310
Specialty
Dental

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Questions and answers

When was Belleglass Point 4 cleared by the FDA?

Belleglass Point 4 (K030646) received a 510(k) decision of Substantially Equivalent on May 6, 2003, 67 days after the submission was received.

What is the product code of K030646?

The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.