FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
A-dec 300, A-dec 500
K Number: K213932
·
Decision Mar 2, 2022
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
283
Applicant Total
69
Review Days
76
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Basic Information
- Device Name
- A-dec 300, A-dec 500
- K Number
- K213932
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- A-Dec, Inc.
- Date Received
- December 16, 2021
- Decision Date
- March 2, 2022
- Product Code
- EIA
- 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 |
|---|---|---|---|
| EIA | Unit, Operative Dental | FDA class 1 | Dental |
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Other Clearances by A-Dec, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K032756 | A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533 | Dec 4, 2003 | Substantially Equivalent |