Product Code: SHI
FDA class 2
21 CFR 872.3660
Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
Dental
510(k)s
2
FEI Numbers
2
Registration Numbers
2
Unique Applicants
2
Years Active
0
Basic Information
- Product Code
- SHI
- Device Class
- FDA class 2
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
An over-the-counter device that is intended to reproduce the structure of a patient's teeth and gums for the fabrication of patient-matched mouthguards/nightguards.
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.