FDA 510(k)

SancDam Latex Oral Dam

K-Number: K212037 · 2022-03-28

Decision Date2022-03-28

Product CodeMSC

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

SancDam Latex Oral Dam is the device name listed in this FDA 510(k) record. The listed applicant is Sanctuary Health Sdn. Bhd.. It received FDA 510(k) clearance on 2022-03-28 under 510(k) 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. The listed applicant is Sanctuary Health Sdn. Bhd.. The 510(k) number is K212037.

When did SancDam Latex Oral Dam receive FDA 510(k) clearance?

SancDam Latex Oral Dam received FDA 510(k) clearance on 2022-03-28, under 510(k) number K212037.

Who is the listed applicant for SancDam Latex Oral Dam?

The FDA 510(k) record lists Sanctuary Health Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

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)

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.

K253662LIXI (LXOSFM1)Luwi, LLC K212928LoralsBrazen Goods Inc. Dba Lorals K203727Harmony Latex Dam, Harmony Non-Latex DamPamco Distributing, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.