FDA 510(k)

1 STEP

K-Number: K792003 · 1979-11-27

Decision Date1979-11-27

Product CodeDYH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

1 STEP is the device name listed in this FDA 510(k) record. The listed applicant is Betta Dental, Inc.. It received FDA 510(k) clearance on 1979-11-27 under 510(k) number K792003. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 1 STEP?

1 STEP is a medical device that received FDA 510(k) clearance on 1979-11-27. The listed applicant is Betta Dental, Inc.. The 510(k) number is K792003.

When did 1 STEP receive FDA 510(k) clearance?

1 STEP received FDA 510(k) clearance on 1979-11-27, under 510(k) number K792003.

Who is the listed applicant for 1 STEP?

The FDA 510(k) record lists Betta Dental, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 1 STEP?

The FDA product code for 1 STEP is DYH.

Related Devices (Code: DYH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261129OrthoFitSpident Co., Ltd.K261840BracePaste Prime PlusAmerican Orthodontics K250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveOrmco Corporation K242537BracePaste Fluoride SealantAmerican Orthodontics Corp.K2340433M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic Products K231817AlignerFlow LCVoco GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.