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FDA 510(k)

ORAL BOND

K-Number: K142130 · 2016-06-06

ApplicantSteiner Laboratories
Decision Date2016-06-06
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORAL BOND is a medical device manufactured by Steiner Laboratories. It received FDA 510(k) clearance on 2016-06-06 under approval number K142130. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORAL BOND?

ORAL BOND is a medical device that received FDA 510(k) clearance on 2016-06-06. It is manufactured by Steiner Laboratories. The 510(k) number is K142130.

When was ORAL BOND approved by the FDA?

ORAL BOND received FDA 510(k) clearance on 2016-06-06, under approval number K142130.

What company makes ORAL BOND?

ORAL BOND is manufactured by Steiner Laboratories.

What is the FDA product code for ORAL BOND?

The FDA product code for ORAL BOND is EMA.

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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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