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FDA PRODUCT CODE · CLASS II

PYQRfid Chip For Dental Appliance

The device is intended to enable access to secure patient identification and device information when used with complete dentures, partial dentures, and other removable oral appliances.

DEVICE CLASS
Class II
REGULATION
21 CFR 880.6300
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
HO
ImplantLife-sustainingGMP-exemptThird-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industryMedical device quality (ISO 13485)FDA device clearancesFDA enforcement & recalls

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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