FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Peak Universal Bond
K Number: K240743
·
Decision Mar 20, 2024
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
103
Review Days
2
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Basic Information
- Device Name
- Peak Universal Bond
- K Number
- K240743
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ultradent Products, Inc.
- Date Received
- March 18, 2024
- Decision Date
- March 20, 2024
- Product Code
- KLE
- 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 |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | FDA class 2 | Dental |
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