NMW · Class I — Low Risk (general controls) · Dental · 21 CFR 872.4730
Classification
FDA Product Code
NMW
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 872.4730
Review panel
DE
Medical specialty
Dental
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
Definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).