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FDA 510(k)

KOLOR +

K-Number: K961284 · 1996-05-08

ApplicantSybron Dental Specialties, Inc.
Decision Date1996-05-08
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KOLOR + 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 1996-05-08 under 510(k) number K961284. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOLOR +?

KOLOR + is a medical device that received FDA 510(k) clearance on 1996-05-08. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K961284.

When did KOLOR + receive FDA 510(k) clearance?

KOLOR + received FDA 510(k) clearance on 1996-05-08, under 510(k) number K961284.

Who is the listed applicant for KOLOR +?

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 KOLOR +?

The FDA product code for KOLOR + is EBF.

Related Clinical Trials

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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: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, 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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