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FDA 510(k)

PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE

K-Number: K014133 · 2002-03-14

ApplicantPulpdent Corp.
Decision Date2002-03-14
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corp.. It received FDA 510(k) clearance on 2002-03-14 under 510(k) number K014133. 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 PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE?

PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE is a medical device that received FDA 510(k) clearance on 2002-03-14. The listed applicant is Pulpdent Corp.. The 510(k) number is K014133.

When did PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE receive FDA 510(k) clearance?

PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE received FDA 510(k) clearance on 2002-03-14, under 510(k) number K014133.

Who is the listed applicant for PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE?

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

What is the FDA product code for PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE?

The FDA product code for PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE is DYH.

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Other records listing Pulpdent Corp. as applicant

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.

K014138PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENTK020115PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEMK014059PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVEK013411PULPDENT CAVITY PREPARATION IVK994180PULPDENT CAVITY PREPARATION IIIK994181PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE

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Related Devices (Code: DYH)

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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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