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KöR

EVOLVE DENTAL TECHNOLOGIES, INC. · Model KöR Complete Desensitizer - 10mL · UDI-DI 00850362007106

EJK Prescription
10
510(k) clearances
14
Adverse events
1
Recalls
49
Facilities

Description

Tooth desensitizer for reduction or elimination of teeth sensitivity during teeth whitening and all other desensitizing needs.

Recalls

DateFirmReason
2014-06-05Axcentria Pharmaceuticals, LLCOne lot of Calcium Hydroxide Powder is being recalled because it was manufactured and distributed without an approved 510k, and the current label does not include instructions for

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data 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.