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FDA 510(k)

ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285

K-Number: K994211 · 2000-02-04

ApplicantDentsply Intl.
Decision Date2000-02-04
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285 is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 2000-02-04 under 510(k) number K994211. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285?

ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285 is a medical device that received FDA 510(k) clearance on 2000-02-04. The listed applicant is Dentsply Intl.. The 510(k) number is K994211.

When did ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285 receive FDA 510(k) clearance?

ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285 received FDA 510(k) clearance on 2000-02-04, under 510(k) number K994211.

Who is the listed applicant for ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285?

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

What is the FDA product code for ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285?

The FDA product code for ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285 is KKX.

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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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