FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ABUTMENT GLO
K Number: K905303
·
Decision Jun 10, 1991
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
76
Applicant Total
18
Review Days
194
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
- ABUTMENT GLO
- K Number
- K905303
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6030
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Implant Innovations International, Inc.
- Date Received
- November 28, 1990
- Decision Date
- June 10, 1991
- Product Code
- EJR
- 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 |
|---|---|---|---|
| EJR | Agent, Polishing, Abrasive, Oral Cavity | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EJR), ordered by most recent decision date.
AIR-FLOW PLUS Prophylaxis powder
FDA 510(k)
FDA Class 1
·Dental
WHIP MIX PREPPIES PLUS
FDA 510(k)
FDA Class 1
·Dental
NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN
FDA 510(k)
FDA Class 1
·Dental
OSSPRAY SYLC CR
FDA 510(k)
FDA Class 1
·Dental
BUTLER CALCI-FLOR PROPHYLAXIS PASTE
FDA 510(k)
FDA Class 1
·Dental
REMIN PRO
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Implant Innovations International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K935544 | 3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION | Mar 13, 1995 | Substantially Equivalent |
| K932123 | IMPLANT INNOVATION PRE-ANGLED ABUTMENT SYSTEM | May 27, 1994 | Substantially Equivalent |
| K911655 | IMPLARETTE | Oct 21, 1991 | Substantially Equivalent |
| K911701 | G-FLOSS & G-FLOSS II | May 15, 1991 | Substantially Equivalent |
| K891613 | OVERDENTURE ATTACHMENT | Oct 10, 1989 | Substantially Equivalent |
| K891612 | DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA. | Jun 12, 1989 | Substantially Equivalent |
| K891617 | INSERTION TOOLS | May 1, 1989 | Substantially Equivalent |
| K891618 | TITANIUM FORCEPS | Apr 17, 1989 | Substantially Equivalent |
| K891615 | SURGICAL DRILLS | Apr 17, 1989 | Substantially Equivalent |
| K874590 | INNOVATIVE IMPLANTS AND COVER SCREWS | May 11, 1988 | Substantially Equivalent |