3M RelyX Pediatric Resin Modified Glass Ionomer Cement
FDA 510(k) clearance K191122 · decided 2019-05-29
Clearance details
- K-number
- K191122
- Device name
- 3M RelyX Pediatric Resin Modified Glass Ionomer Cement
- Applicant
- 3M Espe Dental Products
- Decision
- Substantially Equivalent
- Date received
- 2019-04-29
- Decision date
- 2019-05-29
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- EMA
- Device class
- 2
- Regulation number
- 872.3275
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Saint Paul, MN, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.