Excel Regular Set

FDA 510(k) K875141 · Reliance Orthodontic Products, Inc.

Substantially Equivalent

510(k) numberK875141

Submission

Device name
Excel Regular Set
Applicant
Reliance Orthodontic Products, Inc.
Itasca, IL, US
Received
December 15, 1987
Decision date
February 26, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DYH – Adhesive, Bracket And Tooth Conditioner, Resin
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3750
Specialty
Dental

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Questions and answers

When was Excel Regular Set cleared by the FDA?

Excel Regular Set (K875141) received a 510(k) decision of Substantially Equivalent on February 26, 1988, 73 days after the submission was received.

What is the product code of K875141?

The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.