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FDA 510(k)

IBOND TOTAL ETCH

K-Number: K083652 · 2009-01-21

ApplicantHeraeus Kulzer,GmbH
Decision Date2009-01-21
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IBOND TOTAL ETCH is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer,GmbH. It received FDA 510(k) clearance on 2009-01-21 under 510(k) number K083652. 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 TOTAL ETCH?

IBOND TOTAL ETCH is a medical device that received FDA 510(k) clearance on 2009-01-21. The listed applicant is Heraeus Kulzer,GmbH. The 510(k) number is K083652.

When did IBOND TOTAL ETCH receive FDA 510(k) clearance?

IBOND TOTAL ETCH received FDA 510(k) clearance on 2009-01-21, under 510(k) number K083652.

Who is the listed applicant for IBOND TOTAL ETCH?

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

What is the FDA product code for IBOND TOTAL ETCH?

The FDA product code for IBOND TOTAL ETCH is KLE.

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Other records listing Heraeus Kulzer,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.

K080338CUTTERSIL ACTIVATOR UNIVERSAL PLUSK073554NEUNK062515RETENTION FLOW OPAQUEK050085OSTEOPAL VK050854PALACOS LV+GK050855PALAMED G

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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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