FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
PROPHYLAXIS PACK
K Number: K950773
·
Decision Mar 31, 1995
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
72
Applicant Total
21
Review Days
38
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
- PROPHYLAXIS PACK
- K Number
- K950773
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Transidyne General Corp.
- Date Received
- February 21, 1995
- Decision Date
- March 31, 1995
- Product Code
- EGS
- 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 |
|---|---|---|---|
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EGS), ordered by most recent decision date.
Disposable Prophy Angle (3399-60, 3399-090, 3399-105)
FDA 510(k)
FDA Class 1
·Dental
Disposable Prophy Angle
FDA 510(k)
FDA Class 1
·Dental
Star E900 Handpiece Series
FDA 510(k)
FDA Class 1
·Dental
General Cutting Straight
FDA 510(k)
FDA Class 1
·Dental
FX Contra
FDA 510(k)
FDA Class 1
·Dental
Smooth Drive contra angle and straight handpieces
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Transidyne General Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K961217 | BODILY FLUID DISPOSAL KIT | Jul 25, 1996 | Substantially Equivalent |
| K955658 | LACERATION TRAY | Jan 25, 1996 | Substantially Equivalent |
| K950743 | ORAL PROCEDURE PACK | Mar 31, 1995 | Unknown |
| K950449 | SURGICAL BUR | Mar 1, 1995 | Substantially Equivalent |
| K950403 | SURGICAL SAW BLADES | Feb 21, 1995 | Substantially Equivalent |
| K924811 | I.V. START KIT | Jun 17, 1993 | Unknown |
| K924243 | TRACHEOSTOMY CARE KIT | Jun 16, 1993 | Unknown |
| K922339 | SUTURE REMOVAL KIT | Dec 11, 1992 | Unknown |
| K922041 | PRIMARY SURGICAL DRESSING TRAY | Nov 6, 1992 | Unknown |
| K897133 | MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT | Mar 30, 1990 | Substantially Equivalent |