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FDA 510(k)

PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM

K-Number: K020115 · 2002-02-28

ApplicantPulpdent Corp.
Decision Date2002-02-28
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corp.. It received FDA 510(k) clearance on 2002-02-28 under 510(k) number K020115. 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 SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM?

PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM is a medical device that received FDA 510(k) clearance on 2002-02-28. The listed applicant is Pulpdent Corp.. The 510(k) number is K020115.

When did PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM receive FDA 510(k) clearance?

PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM received FDA 510(k) clearance on 2002-02-28, under 510(k) number K020115.

Who is the listed applicant for PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM?

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 SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM?

The FDA product code for PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM 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.

K014133PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVEK014138PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENTK014059PULPDENT 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)

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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