FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE
K Number: K023953
·
Decision Feb 14, 2003
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
72
Applicant Total
4
Review Days
79
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Basic Information
- Device Name
- ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE
- K Number
- K023953
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- St. George Technology, Inc.
- Date Received
- November 27, 2002
- Decision Date
- February 14, 2003
- 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 |
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Other Clearances by St. George Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K992176 | EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL | Feb 10, 2000 | Substantially Equivalent |
| K945711 | EXCEL-P FORMULA AUTO-CURE DENTURE BASE | Feb 2, 1995 | Substantially Equivalent |
| K934019 | EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO | Jan 18, 1994 | Substantially Equivalent |