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FDA 510(k)

DENTOCULT SM-STRIP MUTANS

K-Number: K890199 · 1989-03-02

ApplicantOrion Corp.
Decision Date1989-03-02
Product CodeJSI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DENTOCULT SM-STRIP MUTANS is the device name listed in this FDA 510(k) record. The listed applicant is Orion Corp.. It received FDA 510(k) clearance on 1989-03-02 under 510(k) number K890199. The device is classified under product code JSI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTOCULT SM-STRIP MUTANS?

DENTOCULT SM-STRIP MUTANS is a medical device that received FDA 510(k) clearance on 1989-03-02. The listed applicant is Orion Corp.. The 510(k) number is K890199.

When did DENTOCULT SM-STRIP MUTANS receive FDA 510(k) clearance?

DENTOCULT SM-STRIP MUTANS received FDA 510(k) clearance on 1989-03-02, under 510(k) number K890199.

Who is the listed applicant for DENTOCULT SM-STRIP MUTANS?

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

What is the FDA product code for DENTOCULT SM-STRIP MUTANS?

The FDA product code for DENTOCULT SM-STRIP MUTANS is JSI.

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Other records listing Orion 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.

K912391RUBALEX, MODIFICATIONK901637RESUBMITTED MODIFIED RUBALEXK884650RESUBMITTED SCANORAK881506MAMEX DC MAG MG12K881505MAMEX DC MG11K874040MAMEX DC S SL10/MG14

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Related Devices (Code: JSI)

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.

K070691BBL CHROMAGAR 0157Becton, Dickinson & COK974428DIPSTREAKNovamed , Ltd.K891593LISTERIA SELECTIVE ENRICHMENT MEDIUMOxoid U.S.A., Inc.K882182SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326Lakewood Biochemical Co., Inc.K881575SELECTIVE STREPTOCOCCUS AGARAcumedia Manufacturers, Inc.K881572XL AGAR BASEAcumedia Manufacturers, 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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