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FDA 510(k)

FORCE II

K-Number: K895163 · 1989-10-27

ApplicantAmerican Orthodontics
Decision Date1989-10-27
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FORCE II is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics. It received FDA 510(k) clearance on 1989-10-27 under 510(k) number K895163. 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 FORCE II?

FORCE II is a medical device that received FDA 510(k) clearance on 1989-10-27. The listed applicant is American Orthodontics. The 510(k) number is K895163.

When did FORCE II receive FDA 510(k) clearance?

FORCE II received FDA 510(k) clearance on 1989-10-27, under 510(k) number K895163.

Who is the listed applicant for FORCE II?

The FDA 510(k) record lists American Orthodontics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FORCE II?

The FDA product code for FORCE II is DYH.

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Other records listing American Orthodontics as applicant

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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 OrthodonticsK250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveOrmco CorporationK242537BracePaste Fluoride SealantAmerican Orthodontics Corp.K2340433M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic ProductsK231817AlignerFlow LCVoco GmbH

Official Source

View on FDA Database →

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

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