Titan 3 Low Speed Angle Attachments— 510(k) K162397
Substantially EquivalentDentalez, Inc.
FDA 510(k) clearance K162397 for Titan 3 Low Speed Angle Attachments, Substantially Equivalent on 2017-01-19. Applicant: Dentalez, Inc.. Device class: 1.
Clearance details
- Applicant
- Dentalez, Inc.
- Product code
- Code EGS
- Device class
- Class 1
- Regulation
- 21 CFR 872.4200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lancaster, PA, US
Recent devices under product code EGS
view allMore clearances from Dentalez, Inc.
view all- K192412 — SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece
- K173465 — Concentrix MX-AC High-Speed Handpiece
- K153411 — 430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece
- K113301 — CONCENPIECE,HIGH-SPEED HANDPIECE SERIES
- K093072 — STARCARE HANDPIECE MAINTENANCE UNIT
Adverse events under product code EGS
product code EGS- Injury
- 356
- Malfunction
- 759
- Total
- 1,115
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.