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FDA 510(k)

DENTOCULT CULTURE-PADDLE

K-Number: K851164 · 1985-10-29

ApplicantOrion Corp.
Decision Date1985-10-29
Product CodeJJJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DENTOCULT CULTURE-PADDLE is the device name listed in this FDA 510(k) record. The listed applicant is Orion Corp.. It received FDA 510(k) clearance on 1985-10-29 under 510(k) number K851164. The device is classified under product code JJJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTOCULT CULTURE-PADDLE?

DENTOCULT CULTURE-PADDLE is a medical device that received FDA 510(k) clearance on 1985-10-29. The listed applicant is Orion Corp.. The 510(k) number is K851164.

When did DENTOCULT CULTURE-PADDLE receive FDA 510(k) clearance?

DENTOCULT CULTURE-PADDLE received FDA 510(k) clearance on 1985-10-29, under 510(k) number K851164.

Who is the listed applicant for DENTOCULT CULTURE-PADDLE?

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 CULTURE-PADDLE?

The FDA product code for DENTOCULT CULTURE-PADDLE is JJJ.

Related Clinical Trials

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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 SCANORAK890199DENTOCULT SM-STRIP MUTANSK881506MAMEX DC MAG MG12K881505MAMEX DC MG11

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Related Devices (Code: JJJ)

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.

K962762SEQUENTIAL SAMPLE MULTI-PHOTON DETECTORBiotraces, Inc.K946387CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTERCapintec, Inc.K920559ABBOTT VERTEX ANALYZERAbbott LaboratoriesK900087GENESYS 6000 GAMMA COUNTERLaboratory Technologies, Inc.K896202MATRIX(TM)-96Canberra Industries, Inc.K894902SOURCEREROakfield Instruments, Ltd.

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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