A-DEC/W&H ELECTRIC HANDPIECE MOTOR— 510(k) K133776
Substantially EquivalentA-Dec, Inc.
FDA 510(k) clearance K133776 for A-DEC/W&H ELECTRIC HANDPIECE MOTOR, Substantially Equivalent on 2014-05-28. Applicant: A-Dec, Inc.. Device class: 1.
Clearance details
- Applicant
- A-Dec, Inc.
- Product code
- Code EBW
- Device class
- Class 1
- Regulation
- 21 CFR 872.4200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Newberg, OR, US
Recent devices under product code EBW
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view all- K213932 — A-dec 300, A-dec 500
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- K100647 — A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM
- 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
- K082827 — A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.