FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DENTCA Crown and Bridge
K Number: K192806
·
Decision Feb 5, 2020
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
188
Applicant Total
5
Review Days
127
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Basic Information
- Device Name
- DENTCA Crown and Bridge
- K Number
- K192806
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dentca, Inc.
- Date Received
- October 1, 2019
- Decision Date
- February 5, 2020
- Product Code
- EBG
- 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 |
|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | FDA class 2 | Dental |
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Other Clearances by Dentca, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K220042 | Dentca Base Premium, Dentca Base Hi-Impact | Nov 17, 2022 | Substantially Equivalent |
| K172398 | DENTCA DENTURE Teeth | Nov 22, 2017 | Substantially Equivalent |
| K162044 | Dentca Denture Base II | Mar 3, 2017 | Substantially Equivalent |
| K143033 | DENTCA DENTURE BASE | Jul 21, 2015 | Substantially Equivalent |