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FDA 510(k)

IBOND GLUMA INSIDE

K-Number: K022612 · 2002-10-28

ApplicantHeraeus Kulzer, Inc.
Decision Date2002-10-28
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IBOND GLUMA INSIDE is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 2002-10-28 under 510(k) number K022612. 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 IBOND GLUMA INSIDE?

IBOND GLUMA INSIDE is a medical device that received FDA 510(k) clearance on 2002-10-28. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K022612.

When did IBOND GLUMA INSIDE receive FDA 510(k) clearance?

IBOND GLUMA INSIDE received FDA 510(k) clearance on 2002-10-28, under 510(k) number K022612.

Who is the listed applicant for IBOND GLUMA INSIDE?

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

What is the FDA product code for IBOND GLUMA INSIDE?

The FDA product code for IBOND GLUMA INSIDE is KLE.

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Other records listing Heraeus Kulzer, 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.

K091494FLEXITIME FLOWK063062HKBOND 2006K060994MONDIALK052543HERACERAM ZIRKONIAK043504PALAIMPACTK043295VERSYO.DIRECT

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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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