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FDA 510(k)

4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL

K-Number: K920460 · 1992-04-28

ApplicantPulpdent Corp.
Decision Date1992-04-28
Product CodeELL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corp.. It received FDA 510(k) clearance on 1992-04-28 under 510(k) number K920460. The device is classified under product code ELL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL?

4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL is a medical device that received FDA 510(k) clearance on 1992-04-28. The listed applicant is Pulpdent Corp.. The 510(k) number is K920460.

When did 4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL receive FDA 510(k) clearance?

4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL received FDA 510(k) clearance on 1992-04-28, under 510(k) number K920460.

Who is the listed applicant for 4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL?

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 4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL?

The FDA product code for 4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL is ELL.

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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 CEMENTK014133PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVEK020115PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEMK014059PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVEK013411PULPDENT CAVITY PREPARATION IVK994180PULPDENT CAVITY PREPARATION III

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Related Devices (Code: ELL)

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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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