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Mirror Cotton Holders
PRACTICON, INC. · Model 1604-P01 · UDI-DI 00723896010068
10
510(k) clearances
47
Adverse events
1
Recalls
371
Facilities
Description
snap onto size 4 and size 5 mouth mirrors and feature twin tabs to keep both lingual and buccal cotton rolls in place during lower posterior procedures. Easily reversible for left or right quadrants. 100 single-use, disposable holders per bag. Not for use with Zirc mouth mirrors.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-03-23 | Sunstar Americas, Inc. | Product may be contaminated with Burkholderia contaminans. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.