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)

SEITY 37% PHOSPHORIC ACID ETCHANT GEL

K-Number: K112597 · 2011-12-07

ApplicantMycone Dental Supply Co., Inc.
Decision Date2011-12-07
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SEITY 37% PHOSPHORIC ACID ETCHANT GEL is the device name listed in this FDA 510(k) record. The listed applicant is Mycone Dental Supply Co., Inc.. It received FDA 510(k) clearance on 2011-12-07 under 510(k) number K112597. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEITY 37% PHOSPHORIC ACID ETCHANT GEL?

SEITY 37% PHOSPHORIC ACID ETCHANT GEL is a medical device that received FDA 510(k) clearance on 2011-12-07. The listed applicant is Mycone Dental Supply Co., Inc.. The 510(k) number is K112597.

When did SEITY 37% PHOSPHORIC ACID ETCHANT GEL receive FDA 510(k) clearance?

SEITY 37% PHOSPHORIC ACID ETCHANT GEL received FDA 510(k) clearance on 2011-12-07, under 510(k) number K112597.

Who is the listed applicant for SEITY 37% PHOSPHORIC ACID ETCHANT GEL?

The FDA 510(k) record lists Mycone Dental Supply Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEITY 37% PHOSPHORIC ACID ETCHANT GEL?

The FDA product code for SEITY 37% PHOSPHORIC ACID ETCHANT GEL is KLE.

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 Mycone Dental Supply Co., Inc. 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.

K093380MIZZY EXPRESSK032773DIAMOND D HIGH IMPACT DENTURE ACRYLIC

Related Devices (Code: KLE)

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.

K262252MPa Max adhesiveDen-Mat Holdings, LLCK260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.

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.

↑