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FDA 510(k)

COLTENE DRS DENTAL RESTORATIVE SYSTEM

K-Number: K811363 · 1981-06-16

ApplicantColtene, Inc.
Decision Date1981-06-16
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COLTENE DRS DENTAL RESTORATIVE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Coltene, Inc.. It received FDA 510(k) clearance on 1981-06-16 under 510(k) number K811363. 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 COLTENE DRS DENTAL RESTORATIVE SYSTEM?

COLTENE DRS DENTAL RESTORATIVE SYSTEM is a medical device that received FDA 510(k) clearance on 1981-06-16. The listed applicant is Coltene, Inc.. The 510(k) number is K811363.

When did COLTENE DRS DENTAL RESTORATIVE SYSTEM receive FDA 510(k) clearance?

COLTENE DRS DENTAL RESTORATIVE SYSTEM received FDA 510(k) clearance on 1981-06-16, under 510(k) number K811363.

Who is the listed applicant for COLTENE DRS DENTAL RESTORATIVE SYSTEM?

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

What is the FDA product code for COLTENE DRS DENTAL RESTORATIVE SYSTEM?

The FDA product code for COLTENE DRS DENTAL RESTORATIVE SYSTEM is EBF.

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Other records listing Coltene, 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.

K902392COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIALK882800COLTENE PRESIDENT JET REGULAR BODYK873671COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEMK870266COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEMK870047COLTENE RAPIDK863998COLTENE JET-MIXER

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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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