GlassLok Kits, GlassLok Powder, GlassLok Liquid
FDA 510(k) clearance K193388 · decided 2020-04-27
Clearance details
- K-number
- K193388
- Device name
- GlassLok Kits, GlassLok Powder, GlassLok Liquid
- Applicant
- Reliance Orthodontic Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-12-06
- Decision date
- 2020-04-27
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- DYH
- Device class
- 2
- Regulation number
- 872.3750
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Itasca, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.