SancDam Latex Oral Dam
K-Number: K212037 · 2022-03-28
ApplicantSanctuary Health Sdn. Bhd.
Decision Date2022-03-28
Product CodeMSC
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
SancDam Latex Oral Dam is a medical device manufactured by Sanctuary Health Sdn. Bhd.. It received FDA 510(k) clearance on 2022-03-28 under approval number K212037. The device is classified under product code MSC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SancDam Latex Oral Dam?
SancDam Latex Oral Dam is a medical device that received FDA 510(k) clearance on 2022-03-28. It is manufactured by Sanctuary Health Sdn. Bhd.. The 510(k) number is K212037.
When was SancDam Latex Oral Dam approved by the FDA?
SancDam Latex Oral Dam received FDA 510(k) clearance on 2022-03-28, under approval number K212037.
What company makes SancDam Latex Oral Dam?
SancDam Latex Oral Dam is manufactured by Sanctuary Health Sdn. Bhd..
What is the FDA product code for SancDam Latex Oral Dam?
The FDA product code for SancDam Latex Oral Dam is MSC.
Related Devices (Code: MSC)
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.