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FDA 510(k)

SOLUSET CALCIUM DEMINERALIZING SOLUTION

K-Number: K864976 · 1987-02-27

ApplicantEndo Technic Corp.
Decision Date1987-02-27
Product CodeEKS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOLUSET CALCIUM DEMINERALIZING SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Endo Technic Corp.. It received FDA 510(k) clearance on 1987-02-27 under 510(k) number K864976. 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 SOLUSET CALCIUM DEMINERALIZING SOLUTION?

SOLUSET CALCIUM DEMINERALIZING SOLUTION is a medical device that received FDA 510(k) clearance on 1987-02-27. The listed applicant is Endo Technic Corp.. The 510(k) number is K864976.

When did SOLUSET CALCIUM DEMINERALIZING SOLUTION receive FDA 510(k) clearance?

SOLUSET CALCIUM DEMINERALIZING SOLUTION received FDA 510(k) clearance on 1987-02-27, under 510(k) number K864976.

Who is the listed applicant for SOLUSET CALCIUM DEMINERALIZING SOLUTION?

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

What is the FDA product code for SOLUSET CALCIUM DEMINERALIZING SOLUTION?

The FDA product code for SOLUSET CALCIUM DEMINERALIZING SOLUTION is EKS.

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Other records listing Endo Technic 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.

K990908MILLENNIUMK971459DERMALASEK925079LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER)K930756LAPAROSCOPIC IRRIGATION/ASPIRATION HANDPIECEK925114LAPAROSCOPIC INSTRUMENTSK924058TROCAR

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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 DentalK970649HERO 642Micro-MegaK962031QUANTEC SERIES 2000 ENDODONTIC FILESTycom DentalK953604SHAPING HEDSTROM N.T.Sybron Dental Specialties, 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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