FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BRACE (ORAFIX SPECIAL)
K Number: K890290
·
Decision Mar 29, 1989
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
11
Applicant Total
4
Review Days
69
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Basic Information
- Device Name
- BRACE (ORAFIX SPECIAL)
- K Number
- K890290
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Norcliff Thayer, Inc.
- Date Received
- January 19, 1989
- Decision Date
- March 29, 1989
- Product Code
- ECB
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ECB | Unit, Syringe, Air And/Or Water | FDA class 1 | Dental |
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