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FDA 510(k)

OPTIONS FOR STAR DENTAL OPUS I

K-Number: K761264 · 1976-12-23

ApplicantSyntex Corp.
Decision Date1976-12-23
Product CodeDYN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPTIONS FOR STAR DENTAL OPUS I is the device name listed in this FDA 510(k) record. The listed applicant is Syntex Corp.. It received FDA 510(k) clearance on 1976-12-23 under 510(k) number K761264. The device is classified under product code DYN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIONS FOR STAR DENTAL OPUS I?

OPTIONS FOR STAR DENTAL OPUS I is a medical device that received FDA 510(k) clearance on 1976-12-23. The listed applicant is Syntex Corp.. The 510(k) number is K761264.

When did OPTIONS FOR STAR DENTAL OPUS I receive FDA 510(k) clearance?

OPTIONS FOR STAR DENTAL OPUS I received FDA 510(k) clearance on 1976-12-23, under 510(k) number K761264.

Who is the listed applicant for OPTIONS FOR STAR DENTAL OPUS I?

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

What is the FDA product code for OPTIONS FOR STAR DENTAL OPUS I?

The FDA product code for OPTIONS FOR STAR DENTAL OPUS I is DYN.

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Other records listing Syntex 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.

K920314TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION)K843593SURGIPRESS SURGICAL LOOPK780997AMALGAM ALLOYK780769S-100 CT SCANNERK780483FIBER OPTIC HANDPIECEK761331OPUS I OPTION - FIBER OPTIC L SYSTEM

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Related Devices (Code: DYN)

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.

K940769DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTORTerraflexK935758HYGOFLEX SALIVA-EJECTORJ.H.Orsing ABK935616SALIVA EJECTOR DISPOSABLEAsa Instruments S.R.L.K924211EJECTORGlenroe TechnologiesK920492HIGH VACHygoplastic, Inc.K921117MINIDAMDelsan Dental Systems

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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