Dental Dam Silicone

FDA 510(k) K961472 · Worldwide Dental, Inc.

Substantially Equivalent

510(k) numberK961472

Submission

Device name
Dental Dam Silicone
Applicant
Worldwide Dental, Inc.
Concord, MA, US
Received
April 17, 1996
Decision date
August 7, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EIE – Dam, Rubber
Device class
Class I (low risk)
Regulation
21 CFR 872.6300
Specialty
Dental

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More from Kreativ, Inc.

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K945077Instrument,Filling,Plastic,DentalEKJ · Traditional 11/30/1994SE
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Questions and answers

When was Dental Dam Silicone cleared by the FDA?

Dental Dam Silicone (K961472) received a 510(k) decision of Substantially Equivalent on August 7, 1996, 112 days after the submission was received.

What is the product code of K961472?

The FDA product code is EIE – Dam, Rubber, a Class I (low risk) device regulated under 21 CFR 872.6300.