Dmg-Polishable Composite

FDA 510(k) K810813 · Dental-Material Gesellschaft

Substantially Equivalent

510(k) numberK810813

Submission

Device name
Dmg-Polishable Composite
Applicant
Dental-Material Gesellschaft
Walker, MI, US
Received
March 24, 1981
Decision date
April 14, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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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More from Enamelite, LLC

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K810825Polyvinyl Silicone Impression MaterialELW · Traditional 04/14/1981SE

Questions and answers

When was Dmg-Polishable Composite cleared by the FDA?

Dmg-Polishable Composite (K810813) received a 510(k) decision of Substantially Equivalent on April 14, 1981, 21 days after the submission was received.

What is the product code of K810813?

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