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FDA 510(k)

INFIBRA, MODEL 1200

K-Number: K061735 · 2006-09-08

ApplicantGlobal Dental Products, Inc.
Decision Date2006-09-08
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INFIBRA, MODEL 1200 is the device name listed in this FDA 510(k) record. The listed applicant is Global Dental Products, Inc.. It received FDA 510(k) clearance on 2006-09-08 under 510(k) number K061735. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFIBRA, MODEL 1200?

INFIBRA, MODEL 1200 is a medical device that received FDA 510(k) clearance on 2006-09-08. The listed applicant is Global Dental Products, Inc.. The 510(k) number is K061735.

When did INFIBRA, MODEL 1200 receive FDA 510(k) clearance?

INFIBRA, MODEL 1200 received FDA 510(k) clearance on 2006-09-08, under 510(k) number K061735.

Who is the listed applicant for INFIBRA, MODEL 1200?

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

What is the FDA product code for INFIBRA, MODEL 1200?

The FDA product code for INFIBRA, MODEL 1200 is EBI.

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Other records listing Global Dental Products, 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.

K023888CIMOFLUOR

Related Devices (Code: EBI)

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.

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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