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FDA 510(k)

NUMBER 20 R/L SYSTEM

K-Number: K841458 · 1984-05-22

ApplicantPentron Corp.
Decision Date1984-05-22
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NUMBER 20 R/L SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pentron Corp.. It received FDA 510(k) clearance on 1984-05-22 under 510(k) number K841458. 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 NUMBER 20 R/L SYSTEM?

NUMBER 20 R/L SYSTEM is a medical device that received FDA 510(k) clearance on 1984-05-22. The listed applicant is Pentron Corp.. The 510(k) number is K841458.

When did NUMBER 20 R/L SYSTEM receive FDA 510(k) clearance?

NUMBER 20 R/L SYSTEM received FDA 510(k) clearance on 1984-05-22, under 510(k) number K841458.

Who is the listed applicant for NUMBER 20 R/L SYSTEM?

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

What is the FDA product code for NUMBER 20 R/L SYSTEM?

The FDA product code for NUMBER 20 R/L SYSTEM is KLE.

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Other records listing Pentron 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.

K021457FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIALK874189DUAL-CURE RADIOPAQUEK874275OPTEC SUPPLEMENTARY KITK874162OPTEC STAIN CHARACTERIZATION AND MODIFICATION KITK873683CODE #23 R SYSTEM (DENTIN ADHESIVE MATERIAL)K873878#24L SYSTEM

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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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