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FDA 510(k)

S&C-SELF ETCH PR-BOND

K-Number: K042614 · 2004-11-22

ApplicantS & C Polymer GmbH
Decision Date2004-11-22
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

S&C-SELF ETCH PR-BOND is the device name listed in this FDA 510(k) record. The listed applicant is S & C Polymer GmbH. It received FDA 510(k) clearance on 2004-11-22 under 510(k) number K042614. 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 S&C-SELF ETCH PR-BOND?

S&C-SELF ETCH PR-BOND is a medical device that received FDA 510(k) clearance on 2004-11-22. The listed applicant is S & C Polymer GmbH. The 510(k) number is K042614.

When did S&C-SELF ETCH PR-BOND receive FDA 510(k) clearance?

S&C-SELF ETCH PR-BOND received FDA 510(k) clearance on 2004-11-22, under 510(k) number K042614.

Who is the listed applicant for S&C-SELF ETCH PR-BOND?

The FDA 510(k) record lists S & C Polymer GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S&C-SELF ETCH PR-BOND?

The FDA product code for S&C-SELF ETCH PR-BOND is KLE.

Other records listing S & C Polymer GmbH 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.

K091735DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANTK083062ROOT CANAL XRK083766PHOGLASS CEMK082115PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECTK081702CARBOXYLATE CEM, PHOSPHATE CEMK031420S & C -BRACKET ADHESIVES

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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.

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