FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SYNEA - LS LOW-SPEED HANDPIECE
K Number: K993526
·
Decision Jan 11, 2000
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
260
Applicant Total
69
Review Days
85
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
- SYNEA - LS LOW-SPEED HANDPIECE
- K Number
- K993526
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- A-Dec, Inc.
- Date Received
- October 18, 1999
- Decision Date
- January 11, 2000
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EFB), ordered by most recent decision date.
High speed air turbine handpiece
FDA 510(k)
FDA Class 1
·Dental
Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)
FDA 510(k)
FDA Class 1
·Dental
Synea Fusion Handpieces (Intensiv & Profin)
FDA 510(k)
FDA Class 1
·Dental
Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)
FDA 510(k)
FDA Class 1
·Dental
High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)
FDA 510(k)
FDA Class 1
·Dental
Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by A-Dec, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K213932 | A-dec 300, A-dec 500 | Mar 2, 2022 | Substantially Equivalent |
| K133776 | A-DEC/W&H ELECTRIC HANDPIECE MOTOR | May 28, 2014 | Substantially Equivalent |
| K102234 | A-DEC 200 DENTAL SYSTEM | Nov 24, 2010 | Substantially Equivalent |
| K100647 | A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM | Jul 9, 2010 | Substantially Equivalent |
| K082716 | A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43 | Jan 15, 2009 | Substantially Equivalent |
| K082827 | A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT | Jan 7, 2009 | Substantially Equivalent |
| K082985 | A-DEC 334/335 DELIVERY SYSTEM | Dec 17, 2008 | Substantially Equivalent |
| K070663 | A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT | Jul 5, 2007 | Substantially Equivalent |
| K051657 | A-DEC SELF-CONTAINED WATER SYSTEM | Aug 30, 2005 | Substantially Equivalent |
| K032757 | A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE | Dec 10, 2003 | Substantially Equivalent |