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FDA 510(k)

HEMA-PRIMER

K-Number: K895750 · 1989-12-21

ApplicantParkell
Decision Date1989-12-21
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HEMA-PRIMER is the device name listed in this FDA 510(k) record. The listed applicant is Parkell. It received FDA 510(k) clearance on 1989-12-21 under 510(k) number K895750. 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 HEMA-PRIMER?

HEMA-PRIMER is a medical device that received FDA 510(k) clearance on 1989-12-21. The listed applicant is Parkell. The 510(k) number is K895750.

When did HEMA-PRIMER receive FDA 510(k) clearance?

HEMA-PRIMER received FDA 510(k) clearance on 1989-12-21, under 510(k) number K895750.

Who is the listed applicant for HEMA-PRIMER?

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

What is the FDA product code for HEMA-PRIMER?

The FDA product code for HEMA-PRIMER is KLE.

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Other records listing Parkell 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.

K923867METAFILK905032MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIALK900303CONNECTK896719PRIMER-P ADHESIVE AGENTK892003ABRAKADABRA - DENTAL ADHESIVE SYSTEMK884918PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER

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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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