FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TACTILE PLUS DENTAL ELEVATORS
K Number: K850906
·
Decision Apr 12, 1985
Classifications
1
FEI Numbers
226
Registration Numbers
226
Same Product Code
5
Applicant Total
23
Review Days
38
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Basic Information
- Device Name
- TACTILE PLUS DENTAL ELEVATORS
- K Number
- K850906
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Ipco Corp.
- Date Received
- March 5, 1985
- Decision Date
- April 12, 1985
- Product Code
- EMJ
- 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 |
|---|---|---|---|
| EMJ | Elevator, Surgical, Dental | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EMJ), ordered by most recent decision date.
ELEVATOR, ROOT, SINGLE-ENDED
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880/1 TO 890/4 VARIOUS TYPES OF PERIOTEAL ELEVATOR
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680/1 TO 785/2 VARIOUS TYPES & SIZES OF ROOT ELEVA
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BEACH DERIOSTEAL ELEVATOR, #2 STRAIGHT
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PERIOSTEAL ELEVATOR
FDA 510(k)
FDA Class 1
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Other Clearances by Ipco Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K871270 | PERFORM DENTURE BASE RESIN | May 29, 1987 | Substantially Equivalent |
| K850666 | STROBEX ULTRON ELECTROSURGE-DENTAL UNIT | May 29, 1985 | Substantially Equivalent |
| K842836 | SAFE & SOFT MINI PADS & MAXI PADS | Oct 15, 1984 | Substantially Equivalent |
| K842837 | SAFE & SOFT MAXI SHILEDS | Oct 15, 1984 | Substantially Equivalent |
| K842838 | SAFE & SOFT PANTY SHIELDS | Oct 5, 1984 | Substantially Equivalent |
| K841953 | ULTRA SHIELD BRIEFS | Jul 19, 1984 | Substantially Equivalent |
| K840753 | AMBEZE DISPOSABLE INCONTINENCE PANTS | Apr 13, 1984 | Substantially Equivalent |
| K840754 | MAXISHIELD INCONTINENCE CARE SYSTEM | Apr 13, 1984 | Substantially Equivalent |
| K840755 | MINIGARD DISPOSABLE LINERS | Apr 13, 1984 | Substantially Equivalent |
| K800293 | FILE, PULP CANAL | Feb 19, 1980 | Substantially Equivalent |