FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NOVUS BONDING AGENT
K Number: K900301
·
Decision May 15, 1990
Classifications
1
FEI Numbers
166
Registration Numbers
166
Same Product Code
329
Applicant Total
16
Review Days
113
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
- NOVUS BONDING AGENT
- K Number
- K900301
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- The Hygenic Corp.
- Date Received
- January 22, 1990
- Decision Date
- May 15, 1990
- 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 The Hygenic Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K954990 | DENTAL DAM | Jan 26, 1996 | Substantially Equivalent |
| K930764 | ENDO-ICE-PULP TESTER-THERMAL | May 27, 1993 | Substantially Equivalent |
| K905418 | GATES GLIDDEN DRILLS | Jul 25, 1991 | Substantially Equivalent |
| K911225 | TRAY DOUGH | Apr 17, 1991 | Substantially Equivalent |
| K905640 | SOLID CORE GUTTA PERCHA CARRIER | Mar 5, 1991 | Substantially Equivalent |
| K900844 | WEDJETS | Apr 16, 1990 | Substantially Equivalent |
| K894092 | DENTAL ENDODONTIC CEMENT (MODIFICATION) | Jan 10, 1990 | Substantially Equivalent |
| K881826 | ENDO-ICE | Aug 23, 1988 | Substantially Equivalent for Some Indications |
| K873644 | PULP PEN | Oct 27, 1987 | Substantially Equivalent |
| K863393 | ENDOCATER | Jun 11, 1987 | Substantially Equivalent |