FDA 510(k)

DE-BOND 200

K-Number: K883418 · 1989-10-24

Decision Date1989-10-24

Product CodeEKS

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

DE-BOND 200 is the device name listed in this FDA 510(k) record. The listed applicant is Scheu-Dental. It received FDA 510(k) clearance on 1989-10-24 under 510(k) number K883418. The device is classified under product code EKS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DE-BOND 200?

DE-BOND 200 is a medical device that received FDA 510(k) clearance on 1989-10-24. The listed applicant is Scheu-Dental. The 510(k) number is K883418.

When did DE-BOND 200 receive FDA 510(k) clearance?

DE-BOND 200 received FDA 510(k) clearance on 1989-10-24, under 510(k) number K883418.

Who is the listed applicant for DE-BOND 200?

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

What is the FDA product code for DE-BOND 200?

The FDA product code for DE-BOND 200 is EKS.

Related Devices (Code: EKS)

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.

K062856TF ROTARY NICKEL TITANIUM FILEOrmco Corp.K004031NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILESDental Power, Inc.K971319NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILESTycom Dental K970649HERO 642Micro-Mega K962031QUANTEC SERIES 2000 ENDODONTIC FILESTycom Dental K953604SHAPING HEDSTROM N.T.Sybron Dental Specialties, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.