FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM
K Number: K895401
·
Decision Dec 4, 1989
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
6
Review Days
88
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Basic Information
- Device Name
- NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM
- K Number
- K895401
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Rocky Mountain Orthodontics, Inc.
- Date Received
- September 7, 1989
- Decision Date
- December 4, 1989
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
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Other Clearances by Rocky Mountain Orthodontics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K843527 | ORTHOMITE 111 ADHESIVE | Oct 18, 1984 | Substantially Equivalent |
| K780678 | IMPRESSION TRAY | Apr 28, 1978 | Substantially Equivalent |
| K780334 | ADHESIVE, BRACKET AND CONDITIONER RESIN | Mar 28, 1978 | Substantially Equivalent |
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| K780205 | ORTHODONTIC BUCCAL TUBE | Feb 16, 1978 | Substantially Equivalent |