Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT

K-Number: K880562 · 1988-08-19

ApplicantMacrochem Corp.
Decision Date1988-08-19
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent for Some Indications

Device Summary

ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT is the device name listed in this FDA 510(k) record. The listed applicant is Macrochem Corp.. It received FDA 510(k) clearance on 1988-08-19 under 510(k) number K880562. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT?

ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT is a medical device that received FDA 510(k) clearance on 1988-08-19. The listed applicant is Macrochem Corp.. The 510(k) number is K880562.

When did ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT receive FDA 510(k) clearance?

ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT received FDA 510(k) clearance on 1988-08-19, under 510(k) number K880562.

Who is the listed applicant for ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT?

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

What is the FDA product code for ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT?

The FDA product code for ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT is DYH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Macrochem 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.

K890623FLUOREVER(R) DUAL CURE CERAMIC VENEER CEMENTK890608FLUOREVER(R) LIGHT CURE CERAMIC VENEER CEMENTK890494FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFSK861546REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT

Related Devices (Code: DYH)

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.

K261129OrthoFitSpident Co., Ltd.K261840BracePaste Prime PlusAmerican OrthodonticsK250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveOrmco CorporationK242537BracePaste Fluoride SealantAmerican Orthodontics Corp.K2340433M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic ProductsK231817AlignerFlow LCVoco GmbH

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.

↑