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FDA 510(k)

ACID ETCH GEL

K-Number: K882576 · 1988-07-15

ApplicantPulpdent Corp. of America
Decision Date1988-07-15
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACID ETCH GEL is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corp. of America. It received FDA 510(k) clearance on 1988-07-15 under 510(k) number K882576. 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 ACID ETCH GEL?

ACID ETCH GEL is a medical device that received FDA 510(k) clearance on 1988-07-15. The listed applicant is Pulpdent Corp. of America. The 510(k) number is K882576.

When did ACID ETCH GEL receive FDA 510(k) clearance?

ACID ETCH GEL received FDA 510(k) clearance on 1988-07-15, under 510(k) number K882576.

Who is the listed applicant for ACID ETCH GEL?

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

What is the FDA product code for ACID ETCH GEL?

The FDA product code for ACID ETCH GEL is EBF.

Other records listing Pulpdent Corp. of America 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.

K863834EVIDENT MARK 2 APEX LOCATORK854977FIBER MESHK844446BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC.K853447POLYCARB WATER SETK810545PCA PERIOCARE PERIODONTAL DRESSING

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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