FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ION DENTAL RESIN SYSTEM
K Number: K072713
·
Decision Oct 12, 2007
Classifications
1
FEI Numbers
166
Registration Numbers
166
Same Product Code
329
Applicant Total
36
Review Days
17
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
- ION DENTAL RESIN SYSTEM
- K Number
- K072713
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentsply International, Inc.
- Date Received
- September 25, 2007
- Decision Date
- October 12, 2007
- 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 Dentsply International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K160207 | ATLANTIS ISUS Implant Suprastructures | Sep 21, 2016 | Substantially Equivalent |
| K160232 | Disposable Barrier Sleeves and Covers | Jun 7, 2016 | Substantially Equivalent |
| K151439 | ATLANTIS ISUS | Feb 19, 2016 | Substantially Equivalent |
| K152247 | ATLANTIS Crown | Jan 29, 2016 | Substantially Equivalent |
| K151039 | ATLANTIS Abutment for NobelActive 3.0 | Jan 14, 2016 | Substantially Equivalent |
| K151619 | Prime&Bond Elect Universal Dental Adhesive | Oct 30, 2015 | Substantially Equivalent |
| K150535 | Cavitron Touch Ultrasonic Scaling System | Jun 16, 2015 | Substantially Equivalent |
| K142178 | PROROOT MTA WHITE, PROROOT MTA GRAY | Feb 26, 2015 | Substantially Equivalent |
| K131907 | RAYPEX 6 | Jan 31, 2014 | Substantially Equivalent |
| K131644 | ANKYLOS SYNCONE ABUTMENT 5(DEGREE) | Jan 22, 2014 | Substantially Equivalent |