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FDA 510(k)

GATES GLIDDEN DRILLS

K-Number: K905418 · 1991-07-25

ApplicantThe Hygenic Corp.
Decision Date1991-07-25
Product CodeDZA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GATES GLIDDEN DRILLS is the device name listed in this FDA 510(k) record. The listed applicant is The Hygenic Corp.. It received FDA 510(k) clearance on 1991-07-25 under 510(k) number K905418. 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 GATES GLIDDEN DRILLS?

GATES GLIDDEN DRILLS is a medical device that received FDA 510(k) clearance on 1991-07-25. The listed applicant is The Hygenic Corp.. The 510(k) number is K905418.

When did GATES GLIDDEN DRILLS receive FDA 510(k) clearance?

GATES GLIDDEN DRILLS received FDA 510(k) clearance on 1991-07-25, under 510(k) number K905418.

Who is the listed applicant for GATES GLIDDEN DRILLS?

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

What is the FDA product code for GATES GLIDDEN DRILLS?

The FDA product code for GATES GLIDDEN DRILLS is DZA.

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Other records listing The Hygenic 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.

K954990DENTAL DAMK930764ENDO-ICE-PULP TESTER-THERMALK911225TRAY DOUGHK905640SOLID CORE GUTTA PERCHA CARRIERK900301NOVUS BONDING AGENTK900844WEDJETS

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Related Devices (Code: DZA)

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.

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 GmbHK962979S-53 INTRORAL DENTAL SYSTEMDel Medical Systems Corp.K954790PROFILE NICKEL TITANIUM ROTARY INSTRUMENTSTulsa Dental Products, Ltd.K914724ADA SHANK EXTENSIONImplant Corp. of AmericaK901097FILLOCK REAMERIvoclar North America, Inc.K896149ANEST-EZE DENTAL DRILL RA#2Signature One Products, 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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