FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CSR
K Number: K974865
·
Decision Mar 16, 1998
Classifications
1
FEI Numbers
166
Registration Numbers
166
Same Product Code
329
Applicant Total
53
Review Days
77
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
- CSR
- K Number
- K974865
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Parkell, Inc.
- Date Received
- December 29, 1997
- Decision Date
- March 16, 1998
- Product Code
- EBI
- 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 |
|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBI), ordered by most recent decision date.
DB 4000 High Impact Denture Base
FDA 510(k)
FDA Class 2
·Dental
Denture Base
FDA 510(k)
FDA Class 2
·Dental
LuxCreo Flexible Partial Denture Resin
FDA 510(k)
FDA Class 2
·Dental
TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000)
FDA 510(k)
FDA Class 2
·Dental
UltraPrint-Dental Denture UV
FDA 510(k)
FDA Class 2
·Dental
Freeprint® denture flex
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 |