FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE
K Number: K022119
·
Decision Jul 25, 2002
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
260
Applicant Total
9
Review Days
24
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Basic Information
- Device Name
- EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE
- K Number
- K022119
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Electro Medical Systems SA
- Date Received
- July 1, 2002
- Decision Date
- July 25, 2002
- Product Code
- EFB
- 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 |
|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | FDA class 1 | Dental |
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Other Clearances by Electro Medical Systems SA
| K Number | Device Name | ||
|---|---|---|---|
| K022328 | EMS PIEZON MASTER 600 | Aug 13, 2002 | Substantially Equivalent |
| K012445 | EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) | Aug 24, 2001 | Substantially Equivalent |
| K002484 | EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL | Oct 4, 2000 | Substantially Equivalent |
| K992251 | SWISS LITHOCLAST MULTIPURPOSE PROBE | Jul 27, 1999 | Substantially Equivalent |
| K963285 | EMS SWISS LITHOCLAST LITHOTRIPTER | Feb 13, 1997 | Substantially Equivalent |
| K964111 | LITHOVAC SUCTION/ASPIRATION PROBE | Dec 16, 1996 | Substantially Equivalent |
| K953026 | MINIPIEZON | Aug 28, 1995 | Substantially Equivalent |
| K951531 | SWISS LITHOCLAST LITHOTRIPTER | Aug 24, 1995 | Substantially Equivalent |