FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GENERAL PURPOSE DENTAL TRAY
K Number: K962527
·
Decision Aug 1, 1996
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
283
Applicant Total
8
Review Days
35
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Basic Information
- Device Name
- GENERAL PURPOSE DENTAL TRAY
- K Number
- K962527
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medcare Medical Group, Inc.
- Date Received
- June 27, 1996
- Decision Date
- August 1, 1996
- 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 Medcare Medical Group, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973497 | HUBERLOC | Jan 13, 1998 | Substantially Equivalent |
| K970152 | BIOPSY TRAY | Mar 5, 1997 | Substantially Equivalent for Some Indications |
| K962849 | CATHETER INSERTION TRAY | Oct 7, 1996 | Substantially Equivalent |
| K961075 | MEDCARE REGIONAL ANETHESIA KIT | Sep 6, 1996 | Unknown |
| K962328 | SINGLE USE INSTRUMENT TRAY | Aug 9, 1996 | Substantially Equivalent |
| K961880 | MEDCARE SUCTION CONNECTING TUBING | Jul 19, 1996 | Substantially Equivalent |
| K961167 | MEDCARE TRACHEOSTOMY CARE TRAY | Jul 2, 1996 | Unknown |