FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BracePaste Band and Build LC
K Number: K202276
·
Decision Aug 14, 2020
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
192
Applicant Total
45
Review Days
3
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Basic Information
- Device Name
- BracePaste Band and Build LC
- K Number
- K202276
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3750
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- American Orthodontics
- Date Received
- August 11, 2020
- Decision Date
- August 14, 2020
- Product Code
- DYH
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | FDA class 2 | Dental |
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Other Clearances by American Orthodontics
| K Number | Device Name | ||
|---|---|---|---|
| K261840 | BracePaste Prime Plus | Jun 3, 2026 | Substantially Equivalent |
| K232011 | Cleo | Jul 7, 2023 | Substantially Equivalent |
| K181910 | BracePaste MTP Light Cure Primer | Oct 15, 2018 | Substantially Equivalent |
| K172953 | Acid Etchant | Feb 6, 2018 | Substantially Equivalent |
| K160782 | BracePaste Adhesive | Oct 14, 2016 | Substantially Equivalent |
| K143117 | Wire Sterilization Package with Indicators | Oct 29, 2015 | Substantially Equivalent |
| K122753 | EMPOWER CLEAR | Dec 14, 2012 | Substantially Equivalent |
| K080749 | RADIANCE | Aug 4, 2008 | Substantially Equivalent |
| K925012 | PLASTIC CHAIN | Sep 13, 1993 | Substantially Equivalent |
| K926578 | UNI-STICK PLASTIC LIGATURE, MODIFIED | Mar 31, 1993 | Substantially Equivalent |