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)

ALPHA-DENT C-R(R) HYBRID TYPE II COMPOSITE RESIN

K-Number: K942767 · 1994-07-08

ApplicantWallace A. Erickson & Co.
Decision Date1994-07-08
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALPHA-DENT C-R(R) HYBRID TYPE II COMPOSITE RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Wallace A. Erickson & Co.. It received FDA 510(k) clearance on 1994-07-08 under 510(k) number K942767. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHA-DENT C-R(R) HYBRID TYPE II COMPOSITE RESIN?

ALPHA-DENT C-R(R) HYBRID TYPE II COMPOSITE RESIN is a medical device that received FDA 510(k) clearance on 1994-07-08. The listed applicant is Wallace A. Erickson & Co.. The 510(k) number is K942767.

When did ALPHA-DENT C-R(R) HYBRID TYPE II COMPOSITE RESIN receive FDA 510(k) clearance?

ALPHA-DENT C-R(R) HYBRID TYPE II COMPOSITE RESIN received FDA 510(k) clearance on 1994-07-08, under 510(k) number K942767.

Who is the listed applicant for ALPHA-DENT C-R(R) HYBRID TYPE II COMPOSITE RESIN?

The FDA 510(k) record lists Wallace A. Erickson & Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALPHA-DENT C-R(R) HYBRID TYPE II COMPOSITE RESIN?

The FDA product code for ALPHA-DENT C-R(R) HYBRID TYPE II COMPOSITE RESIN is EBF.

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 Wallace A. Erickson & Co. 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.

K984503ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000K963922ALPHA-DENT ROOT CANAL SEALER & FILLERK960667CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDEK960365ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000)K960165ALPHA-DENT COMPOSITE SURFACE SEALANTK960122ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIAL

View all 32 devices →

Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, 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.

↑