FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
DENTAL TRAY
K Number: K941349
·
Decision Jul 26, 1994
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
283
Applicant Total
23
Review Days
127
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Basic Information
- Device Name
- DENTAL TRAY
- K Number
- K941349
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Cush Medical Products
- Date Received
- March 21, 1994
- Decision Date
- July 26, 1994
- Product Code
- EIA
- 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 |
|---|---|---|---|
| EIA | Unit, Operative Dental | FDA class 1 | Dental |
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Other Clearances by Cush Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K943424 | CUSH ISLAND DRESSING | Oct 3, 1994 | Substantially Equivalent for Some Indications |
| K940518 | C-SECTION TRAY | Aug 18, 1994 | Unknown |
| K941645 | BIOPSY TRAY | Jul 14, 1994 | Unknown |
| K940239 | EYE TRAY | Jun 28, 1994 | Unknown |
| K935684 | IV START KIT | Jun 10, 1994 | Unknown |
| K941455 | STERILE GAUZE PRODUCT LINE | May 20, 1994 | Unknown |
| K941522 | STERILE X-RAY DETECTABLE GAUZE SPONGES | May 12, 1994 | Substantially Equivalent |
| K941344 | LAP SPONGE PRODUCT LINE | May 12, 1994 | Substantially Equivalent |
| K935697 | CIRCUMCISION TRAY | May 2, 1994 | Unknown |
| K936120 | LABOR AND DELIVERY TRAY | Mar 30, 1994 | Unknown |