FDA 510(k)

HEMA-GLU

K-Number: K951220 · 1995-05-12

Decision Date1995-05-12

Product CodeKLE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

HEMA-GLU is the device name listed in this FDA 510(k) record. The listed applicant is Health-Dent Intl., Inc.. It received FDA 510(k) clearance on 1995-05-12 under 510(k) number K951220. 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-GLU?

HEMA-GLU is a medical device that received FDA 510(k) clearance on 1995-05-12. The listed applicant is Health-Dent Intl., Inc.. The 510(k) number is K951220.

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

HEMA-GLU received FDA 510(k) clearance on 1995-05-12, under 510(k) number K951220.

Who is the listed applicant for HEMA-GLU?

The FDA 510(k) record lists Health-Dent Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMA-GLU?

The FDA product code for HEMA-GLU is KLE.

Other records listing Health-Dent Intl., 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.

K972198DENT-TEMP ACRYLIC K953405HEMA-BENZ K951380VILA PC K951381VILA K951235GIROC K951236PRO-LOCK

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Related Devices (Code: KLE)

K262252MPa Max adhesiveDen-Mat Holdings, LLC K260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-Pak K252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products Company K251587VITA 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.