FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
G-FLOSS & G-FLOSS II
K Number: K911701
·
Decision May 15, 1991
Classifications
1
FEI Numbers
335
Registration Numbers
336
Same Product Code
61
Applicant Total
18
Review Days
29
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Basic Information
- Device Name
- G-FLOSS & G-FLOSS II
- K Number
- K911701
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6390
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Implant Innovations International, Inc.
- Date Received
- April 16, 1991
- Decision Date
- May 15, 1991
- Product Code
- JES
- 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 |
|---|---|---|---|
| JES | Floss, Dental | FDA class 1 | Dental |
Similar 510(k) Clearances
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CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS
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IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID
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VUTLER G.U.M. WITH FLUORIDE
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JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS
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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 |
| K905303 | ABUTMENT GLO | Jun 10, 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 |