ORTHODONTIC BRACKET— 510(k) K803316
Substantially EquivalentOrec Corp.
FDA 510(k) clearance K803316 for ORTHODONTIC BRACKET, Substantially Equivalent on 1981-01-14. Applicant: Orec Corp.. Device class: 1.
Clearance details
- Applicant
- Orec Corp.
- Product code
- Code EJF
- Device class
- Class 1
- Regulation
- 21 CFR 872.5410
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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