FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABSOLUTE DENTIN 2
K Number: K132115
·
Decision Jun 25, 2014
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
53
Review Days
351
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
- ABSOLUTE DENTIN 2
- K Number
- K132115
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Parkell, Inc.
- Date Received
- July 9, 2013
- Decision Date
- June 25, 2014
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBF), ordered by most recent decision date.
SRGC-06
FDA 510(k)
FDA Class 2
·Dental
DIAFIL
FDA 510(k)
FDA Class 2
·Dental
DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)
FDA 510(k)
FDA Class 2
·Dental
Dual Core
FDA 510(k)
FDA Class 2
·Dental
Dura-Crown
FDA 510(k)
FDA Class 2
·Dental
Grandio disc multicolor
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Parkell, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243254 | Parkell Pit and Fissure Sealant | Aug 8, 2025 | Substantially Equivalent |
| K210259 | Parkell Self-Adhesive Cement | Jan 20, 2022 | Substantially Equivalent |
| K191103 | Parkell Desensitizer Gel | Nov 22, 2019 | Substantially Equivalent |
| K190930 | SmarTemp X1 | Sep 5, 2019 | Substantially Equivalent |
| K182296 | HyperFil-LV | Dec 14, 2018 | Substantially Equivalent |
| K172176 | Parkell Universal Adhesive | Nov 21, 2017 | Substantially Equivalent |
| K151518 | BRUSH&BOND PLUS | Sep 18, 2015 | Substantially Equivalent |
| K142848 | EAZY PRIMER | Feb 24, 2015 | Substantially Equivalent |
| K113839 | RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE | Apr 12, 2012 | Substantially Equivalent |
| K101044 | RETRIEVE IMPLANT CEMENT | Jun 10, 2010 | Substantially Equivalent |