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)

R & S SERIES FITTING TOOLS

K-Number: K811889 · 1981-07-24

ApplicantSuncoast Dental Corp.
Decision Date1981-07-24
Product CodeEIC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

R & S SERIES FITTING TOOLS is the device name listed in this FDA 510(k) record. The listed applicant is Suncoast Dental Corp.. It received FDA 510(k) clearance on 1981-07-24 under 510(k) number K811889. The device is classified under product code EIC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R & S SERIES FITTING TOOLS?

R & S SERIES FITTING TOOLS is a medical device that received FDA 510(k) clearance on 1981-07-24. The listed applicant is Suncoast Dental Corp.. The 510(k) number is K811889.

When did R & S SERIES FITTING TOOLS receive FDA 510(k) clearance?

R & S SERIES FITTING TOOLS received FDA 510(k) clearance on 1981-07-24, under 510(k) number K811889.

Who is the listed applicant for R & S SERIES FITTING TOOLS?

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

What is the FDA product code for R & S SERIES FITTING TOOLS?

The FDA product code for R & S SERIES FITTING TOOLS is EIC.

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 Suncoast Dental 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.

K811923R & S SERIES IMPLANTS

Related Devices (Code: EIC)

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.

K972234RCT GEL ROOT CANAL THERAPY GELDentsply Intl.K864307MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI)Smith & Nephew, Inc.K861846HYDRON ROOT CANAL FILLING & MARK IV STARTER KITSolar Dental Co., Inc.K851944MAX-I-PROBE HANDPIECESolo Pak LaboratoriesK840237MAX-I-PROBE PERIODONTAL ENDODONTIC PROBSmith & Nephew, Mpl DivisionK811594WATER PISTOLAus-Tex Dental Mfg. & Design

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.

↑