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FDA 510(k)

HYDENT

K-Number: K911259 · 1991-06-06

ApplicantPascal Co., Inc.
Decision Date1991-06-06
Product CodeEFH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HYDENT is the device name listed in this FDA 510(k) record. The listed applicant is Pascal Co., Inc.. It received FDA 510(k) clearance on 1991-06-06 under 510(k) number K911259. The device is classified under product code EFH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDENT?

HYDENT is a medical device that received FDA 510(k) clearance on 1991-06-06. The listed applicant is Pascal Co., Inc.. The 510(k) number is K911259.

When did HYDENT receive FDA 510(k) clearance?

HYDENT received FDA 510(k) clearance on 1991-06-06, under 510(k) number K911259.

Who is the listed applicant for HYDENT?

The FDA 510(k) record lists Pascal Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYDENT?

The FDA product code for HYDENT is EFH.

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Other records listing Pascal Co., Inc. 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.

K102526BLO2X OXYGEN BLOCKERK090597FLUORILAQ SODIUM FLUORIDE CAVITY VARNISHK040988ZIRCON-F PROPHYLAXIS PASTEK040661RADENT PROPHY PASTEK012889BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANTK030488FLUORILAQ

View all 8 devices →

Related Devices (Code: EFH)

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.

K965026PFINGST PRESSURE PASTEPfingst & Co., Inc.K912632OCCLUDEPascal Co., Inc.K864572FIXTECTORProdent Intl., Inc.K870032REVISED T-SCAN SYSTEMSentek, Inc.K832647ARTICULATING PAPERArdent Intl., Inc.K833132MUCOSAL ADJUSTMENT PASTE LIQUID SPRAYMyo-Tronics Research, 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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