FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER
K Number: K103158
·
Decision Feb 7, 2011
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
72
Applicant Total
2
Review Days
104
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Basic Information
- Device Name
- STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER
- K Number
- K103158
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Angstrom Mfg., Inc.
- Date Received
- October 26, 2010
- Decision Date
- February 7, 2011
- 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 Angstrom Mfg., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K103157 | DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE | Jan 24, 2011 | Substantially Equivalent |