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FDA 510(k)

2.5% NITRIC ACID ETCHING GEL

K-Number: K920484 · 1992-04-28

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

Device Summary

2.5% NITRIC ACID 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 K920484. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 2.5% NITRIC ACID ETCHING GEL?

2.5% NITRIC ACID 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 K920484.

When did 2.5% NITRIC ACID ETCHING GEL receive FDA 510(k) clearance?

2.5% NITRIC ACID ETCHING GEL received FDA 510(k) clearance on 1992-04-28, under 510(k) number K920484.

Who is the listed applicant for 2.5% NITRIC ACID 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 2.5% NITRIC ACID ETCHING GEL?

The FDA product code for 2.5% NITRIC ACID ETCHING GEL is EBF.

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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: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, Inc.

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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