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FDA 510(k)

3D/DENTAL

K-Number: K885322 · 1989-02-09

ApplicantColumbia Scientific, Inc.
Decision Date1989-02-09
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3D/DENTAL is the device name listed in this FDA 510(k) record. The listed applicant is Columbia Scientific, Inc.. It received FDA 510(k) clearance on 1989-02-09 under 510(k) number K885322. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3D/DENTAL?

3D/DENTAL is a medical device that received FDA 510(k) clearance on 1989-02-09. The listed applicant is Columbia Scientific, Inc.. The 510(k) number is K885322.

When did 3D/DENTAL receive FDA 510(k) clearance?

3D/DENTAL received FDA 510(k) clearance on 1989-02-09, under 510(k) number K885322.

Who is the listed applicant for 3D/DENTAL?

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

What is the FDA product code for 3D/DENTAL?

The FDA product code for 3D/DENTAL is JAK.

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Other records listing Columbia Scientific, 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.

K011180CT/MASTER, VERSION 1.0K924810SIM/PLANTK897000IMAGEMASTER-101(TM)K880404CSI/QCTK870513CSI/3DK861852CSI/MPR OR CSI/MPR PLUS

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Related Devices (Code: JAK)

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.

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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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