DENTAL INSTRUMENTS - FILES— 510(k) K823316
Substantially EquivalentMiltex, Inc.
FDA 510(k) clearance K823316 for DENTAL INSTRUMENTS - FILES, Substantially Equivalent on 1982-11-24. Applicant: Miltex, Inc.. Device class: 1.
Clearance details
- Applicant
- Miltex, Inc.
- Product code
- Code EKS
- Device class
- Class 1
- Regulation
- 21 CFR 872.4565
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code EKS
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view all- K101653 — MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES
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- K083796 — MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT
- K072563 — MILTEX RIGID CONTAINER SYSTEMS
- K061033 — MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS)
Adverse events under product code EKS
product code EKS- Malfunction
- 1,949
- Total
- 1,949
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.