FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRI-PHASIX CHROMATIC ALGINATE
K Number: K962741
·
Decision Sep 6, 1996
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
53
Review Days
53
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
- TRI-PHASIX CHROMATIC ALGINATE
- K Number
- K962741
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Parkell, Inc.
- Date Received
- July 15, 1996
- Decision Date
- September 6, 1996
- Product Code
- ELW
- 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 |
|---|---|---|---|
| ELW | Material, Impression | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ELW), ordered by most recent decision date.
Dia-X Sil Bite
FDA 510(k)
FDA Class 2
·Dental
Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);
FDA 510(k)
FDA Class 2
·Dental
JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST
FDA 510(k)
FDA Class 2
·Dental
Elastic Impression Material
FDA 510(k)
FDA Class 2
·Dental
Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator
FDA 510(k)
FDA Class 2
·Dental
Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu
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 |
| K132115 | ABSOLUTE DENTIN 2 | Jun 25, 2014 | Substantially Equivalent |
| K113839 | RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE | Apr 12, 2012 | Substantially Equivalent |