FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMPLARETTE
K Number: K911655
·
Decision Oct 21, 1991
Classifications
1
FEI Numbers
99
Registration Numbers
99
Same Product Code
71
Applicant Total
18
Review Days
192
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
- IMPLARETTE
- K Number
- K911655
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Implant Innovations International, Inc.
- Date Received
- April 12, 1991
- Decision Date
- October 21, 1991
- Product Code
- EKJ
- 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 |
|---|---|---|---|
| EKJ | Burnisher, Operative | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EKJ), ordered by most recent decision date.
ASEPTYLUM, UNI-CARRIER
FDA 510(k)
FDA Class 1
·Dental
MEDTROL DENTAL KIT
FDA 510(k)
FDA Class 1
·Dental
DENTAL KIT
FDA 510(k)
FDA Class 1
·Dental
SUREFLEX FILES
FDA 510(k)
FDA Class 1
·Dental
INSTRUMENT,FILLING,PLASTIC,DENTAL
FDA 510(k)
FDA Class 1
·Dental
STAT PAK
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 |
| K905303 | ABUTMENT GLO | Jun 10, 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 |