FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive
K Number: K250015
·
Decision Jan 3, 2025
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
192
Applicant Total
6
Review Days
1
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Basic Information
- Device Name
- Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive
- K Number
- K250015
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3750
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ormco Corporation
- Date Received
- January 2, 2025
- Decision Date
- January 3, 2025
- 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 Ormco Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K250487 | SparkTM Clear Aligner System | Feb 20, 2025 | Substantially Equivalent |
| K240501 | Spark Clear Aligner System | Oct 11, 2024 | Substantially Equivalent |
| K203737 | Spark Clear Aligner System | Mar 22, 2021 | Substantially Equivalent |
| K172845 | Symetri Clear | Jan 31, 2018 | Substantially Equivalent |
| K171844 | Inspire ICE aka Inspire ICE Clear Brackets | Jul 18, 2017 | Substantially Equivalent |