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FDA 510(k)

SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS

K-Number: K964179 · 1997-01-09

ApplicantS.S. White Mfg., Ltd.
Decision Date1997-01-09
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS is the device name listed in this FDA 510(k) record. The listed applicant is S.S. White Mfg., Ltd.. It received FDA 510(k) clearance on 1997-01-09 under 510(k) number K964179. 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 SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS?

SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS is a medical device that received FDA 510(k) clearance on 1997-01-09. The listed applicant is S.S. White Mfg., Ltd.. The 510(k) number is K964179.

When did SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS receive FDA 510(k) clearance?

SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS received FDA 510(k) clearance on 1997-01-09, under 510(k) number K964179.

Who is the listed applicant for SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS?

The FDA 510(k) record lists S.S. White Mfg., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS?

The FDA product code for SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS 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 S.S. White Mfg., Ltd. 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.

K972935SUPER-DENT INTERMEDIATE RESTORATIVE MATERIALK965083SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORMAL SET, DELUXE DUTLESS ALGINATE, FAST SET

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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