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FDA 510(k)

LIP BUMPER

K-Number: K890656 · 1989-04-17

ApplicantAmerican Orthodontics
Decision Date1989-04-17
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LIP BUMPER is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics. It received FDA 510(k) clearance on 1989-04-17 under 510(k) number K890656. The device is classified under product code EJF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIP BUMPER?

LIP BUMPER is a medical device that received FDA 510(k) clearance on 1989-04-17. The listed applicant is American Orthodontics. The 510(k) number is K890656.

When did LIP BUMPER receive FDA 510(k) clearance?

LIP BUMPER received FDA 510(k) clearance on 1989-04-17, under 510(k) number K890656.

Who is the listed applicant for LIP BUMPER?

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 LIP BUMPER?

The FDA product code for LIP BUMPER is EJF.

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Related Devices (Code: EJF)

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.

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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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