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Medi Guard Dental Bib

by Sancella, Inc.

510(k) K911944

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK911944 Date4 Oct 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KKX
Device Class
Class II
Regulation
21 CFR Part 878.4370
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Medi Guard Dental Bib is a dental bib device. It is substantially equivalent to a predicate device and received traditional 510(k) clearance from the FDA.

The device was manufactured by Sancella, Inc. in Oakville, Ontario, Canada. It is classified under product code KKX and advisory committee SU (General, Plastic Surgery). The clearance decision was made on October 4, 1991, with application received on May 1, 1991.

Other devices from Sancella, Inc.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Medi Guard Dental Bib used for?

    The Medi Guard Dental Bib is a dental bib device designed for use in dental procedures to protect patient clothing from fluids and debris, as indicated by its classification under product code KKX and advisory committee SU for General, Plastic Surgery applications.

  • How was the Medi Guard Dental Bib cleared for market release?

    The Medi Guard Dental Bib received traditional 510(k) clearance from the FDA on October 4, 1991, after being determined substantially equivalent to a predicate device, with the application received on May 1, 1991, by Sancella, Inc.

  • Who manufactures the Medi Guard Dental Bib and where is it produced?

    The Medi Guard Dental Bib is manufactured by Sancella, Inc. at their facility located at 6-2300 Bristol Cir., Oakville, Ontario L6h 5s2, Canada, as specified in the device authorization records.