FDA 510(k)

HANDPIECE, DENTAL

K-Number: K801888 · 1980-08-20

Decision Date1980-08-20

Product CodeDZA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

HANDPIECE, DENTAL is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Instruments Corp.. It received FDA 510(k) clearance on 1980-08-20 under 510(k) number K801888. The device is classified under product code DZA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANDPIECE, DENTAL?

HANDPIECE, DENTAL is a medical device that received FDA 510(k) clearance on 1980-08-20. The listed applicant is Aesculap Instruments Corp.. The 510(k) number is K801888.

When did HANDPIECE, DENTAL receive FDA 510(k) clearance?

HANDPIECE, DENTAL received FDA 510(k) clearance on 1980-08-20, under 510(k) number K801888.

Who is the listed applicant for HANDPIECE, DENTAL?

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

What is the FDA product code for HANDPIECE, DENTAL?

The FDA product code for HANDPIECE, DENTAL is DZA.

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Other records listing Aesculap Instruments Corp. as applicant

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Related Devices (Code: DZA)

K984508SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MODW&H Dentalwerk Buermoos GmbH K962979S-53 INTRORAL DENTAL SYSTEMDel Medical Systems Corp.K954790PROFILE NICKEL TITANIUM ROTARY INSTRUMENTSTulsa Dental Products, Ltd.K914724ADA SHANK EXTENSIONImplant Corp. of America K905418GATES GLIDDEN DRILLSThe Hygenic Corp.K901097FILLOCK REAMERIvoclar North 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.