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FDA 510(k)

COLTENE ORALLY

K-Number: K810907 · 1981-04-23

ApplicantColtene, Inc.
Decision Date1981-04-23
Product CodeEJJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COLTENE ORALLY is the device name listed in this FDA 510(k) record. The listed applicant is Coltene, Inc.. It received FDA 510(k) clearance on 1981-04-23 under 510(k) number K810907. The device is classified under product code EJJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLTENE ORALLY?

COLTENE ORALLY is a medical device that received FDA 510(k) clearance on 1981-04-23. The listed applicant is Coltene, Inc.. The 510(k) number is K810907.

When did COLTENE ORALLY receive FDA 510(k) clearance?

COLTENE ORALLY received FDA 510(k) clearance on 1981-04-23, under 510(k) number K810907.

Who is the listed applicant for COLTENE ORALLY?

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 ORALLY?

The FDA product code for COLTENE ORALLY is EJJ.

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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: EJJ)

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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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