FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROPHYLAXIS ANGLE
K Number: K780752
·
Decision May 26, 1978
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
72
Applicant Total
16
Review Days
18
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 ANGLE
- K Number
- K780752
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Young Dental Manufacturing Co. 1, LLC
- Date Received
- May 8, 1978
- Decision Date
- May 26, 1978
- 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 Young Dental Manufacturing Co. 1, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K241041 | Silver Fluoride Hypersensitivity Varnish | Feb 28, 2025 | Substantially Equivalent |
| K201127 | DEFEND Ear-loop Face Masks | Apr 14, 2021 | Substantially Equivalent |
| K171377 | Young INFINITY Cordless Handpiece System | Aug 20, 2018 | Substantially Equivalent |
| K153334 | Oral-B 5% Sodium Fluoride Varnish | May 20, 2016 | Substantially Equivalent |
| K932255 | YOUNG D'GRANULATOR | Apr 15, 1994 | Substantially Equivalent |
| K903284 | YOUNG PROPHY SYSTEM, PS UNIT | Dec 17, 1990 | Substantially Equivalent |
| K875340 | JETPOLISHER(TM) | Jun 10, 1988 | Substantially Equivalent |
| K875339 | JETPOLISHER AIRPOLISHING POWDER | Apr 18, 1988 | Substantially Equivalent |
| K821484 | DAWN LOW SPEED HANDPIECE SYSTEM | Jun 9, 1982 | Substantially Equivalent |
| K790723 | PROPHYLAXIS CUPS AND POLISHERS | Jun 15, 1979 | Substantially Equivalent |