A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM— 510(k) K100647
Substantially EquivalentA-Dec, Inc.
FDA 510(k) clearance K100647 for A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM, Substantially Equivalent on 2010-07-09. Applicant: A-Dec, Inc.. Device class: 2.
Clearance details
- Applicant
- A-Dec, Inc.
- Product code
- Code ELC
- Device class
- Class 2
- Regulation
- 21 CFR 872.4850
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newberg, OR, US
Recent devices under product code ELC
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view all- K213932 — A-dec 300, A-dec 500
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- K102234 — A-DEC 200 DENTAL SYSTEM
- 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
Adverse events under product code ELC
product code ELC- Malfunction
- 1,255
- Total
- 1,255
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.