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FDA 510(k)

CONNECT

K-Number: K954689 · 1995-10-30

ApplicantSybron Dental Specialties, Inc.
Decision Date1995-10-30
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CONNECT is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Dental Specialties, Inc.. It received FDA 510(k) clearance on 1995-10-30 under 510(k) number K954689. 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 CONNECT?

CONNECT is a medical device that received FDA 510(k) clearance on 1995-10-30. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K954689.

When did CONNECT receive FDA 510(k) clearance?

CONNECT received FDA 510(k) clearance on 1995-10-30, under 510(k) number K954689.

Who is the listed applicant for CONNECT?

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

What is the FDA product code for CONNECT?

The FDA product code for CONNECT is EBI.

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Related PubMed Literature

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.

PMID: 36258781The Complex Process of Using the Interconnected Knee Arthroplasty Device Clearance Pathway.HSS journal : the musculoskeletal journal of Hospital for Special Surgery ()PMID: 34161960The Interconnected Ancestral Network of Hip Arthroplasty Device Approval.The Journal of the American Academy of Orthopaedic Surgeons ()

Other records listing Sybron Dental Specialties, 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.

K093341CENTURY MODEL 105CK091091SONICFILL 2010K080089SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPSK073478SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTSK071615FIXAFLOSSK071288MODIFICATION TO KAVO QUATTROCARE

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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

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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