FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Suglue 3
K Number: K192992
·
Decision Nov 5, 2019
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
12
Review Days
11
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Suglue 3
- K Number
- K192992
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3M Deutschland GmbH
- Date Received
- October 25, 2019
- Decision Date
- November 5, 2019
- Product Code
- EMA
- 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 |
|---|---|---|---|
| EMA | Cement, Dental | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EMA), ordered by most recent decision date.
G-CEM UNIVERSAL
FDA 510(k)
FDA Class 2
·Dental
REGEN Bioactive Cement
FDA 510(k)
FDA Class 2
·Dental
Bifix Veneer LC, Bifix Veneer Try-In
FDA 510(k)
FDA Class 2
·Dental
iCEM Universal Plus
FDA 510(k)
FDA Class 2
·Dental
TopCEM Vigor SA Self-Adhesive Resin Cement
FDA 510(k)
FDA Class 2
·Dental
GlasIonomer FX-LC
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by 3M Deutschland GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K220257 | Permadyne | Feb 1, 2022 | Substantially Equivalent |
| K192961 | ADH19 | Oct 31, 2019 | Substantially Equivalent |
| K173318 | Rapid HB, Rapid LB, Rapid MB | Oct 31, 2017 | Substantially Equivalent |
| K161922 | XP202 | Sep 1, 2016 | Substantially Equivalent |
| K153174 | Ketac Universal Aplicap | Apr 13, 2016 | Substantially Equivalent |
| K151748 | Clean & More | Mar 11, 2016 | Substantially Equivalent |
| K151144 | SuPro 100 | Sep 14, 2015 | Substantially Equivalent |
| K140684 | CLINPRO PROPHY POWDER | Oct 24, 2014 | Substantially Equivalent |
| K133436 | FLASH AR; FLASH AR QUICK | Mar 7, 2014 | Substantially Equivalent |
| K131404 | FLASH AR PENTA / FLASH AR PENTA QUICK | May 30, 2013 | Substantially Equivalent |