FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PacBond One
K Number: K210186
·
Decision Jul 16, 2021
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
8
Review Days
172
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Basic Information
- Device Name
- PacBond One
- K Number
- K210186
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pac-Dent, Inc.
- Date Received
- January 25, 2021
- Decision Date
- July 16, 2021
- Product Code
- KLE
- 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 |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | FDA class 2 | Dental |
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Other Clearances by Pac-Dent, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K202674 | Medidenta High Speed Handpieces | Dec 12, 2022 | Substantially Equivalent |
| K202920 | OptiComp | May 25, 2022 | Substantially Equivalent |
| K202831 | The iMask Child's Face Mask | Aug 26, 2021 | Substantially Equivalent |
| K210189 | Pac-Dent Denture Base Resin | Jul 28, 2021 | Substantially Equivalent |
| K210412 | Pac-Dent Ceramic Nanohybrid Resin | Jul 26, 2021 | Substantially Equivalent |
| K201182 | iMask Disposable Surgical Face Mask | Feb 19, 2021 | Substantially Equivalent |
| K200330 | RC-Prime Root Canal Preparation Cream | Jul 6, 2020 | Substantially Equivalent |