FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Pac-Dent Denture Base Resin
K Number: K210189
·
Decision Jul 28, 2021
Classifications
1
FEI Numbers
166
Registration Numbers
166
Same Product Code
329
Applicant Total
8
Review Days
184
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
- Pac-Dent Denture Base Resin
- K Number
- K210189
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pac-Dent, Inc.
- Date Received
- January 25, 2021
- Decision Date
- July 28, 2021
- 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 Pac-Dent, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K202674 | Medidenta High Speed Handpieces | Dec 12, 2022 | Substantially Equivalent |
| K202920 | OptiComp | May 25, 2022 | Substantially Equivalent |
| K202831 | The iMask Child's Face Mask | Aug 26, 2021 | Substantially Equivalent |
| K210412 | Pac-Dent Ceramic Nanohybrid Resin | Jul 26, 2021 | Substantially Equivalent |
| K210186 | PacBond One | Jul 16, 2021 | Substantially Equivalent |
| K201182 | iMask Disposable Surgical Face Mask | Feb 19, 2021 | Substantially Equivalent |
| K200330 | RC-Prime Root Canal Preparation Cream | Jul 6, 2020 | Substantially Equivalent |