JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD— 510(k) K100653
Substantially EquivalentLang Dental Mfg. Co., Inc.
FDA 510(k) clearance K100653 for JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD, Substantially Equivalent on 2010-10-08. Applicant: Lang Dental Mfg. Co., Inc.. Device class: 2.
Clearance details
- Applicant
- Lang Dental Mfg. Co., Inc.
- Product code
- Code EBI
- Device class
- Class 2
- Regulation
- 21 CFR 872.3760
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wheeling, IL, US
Recent devices under product code EBI
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- K081981 — LANG DENTAL ACRYLIC PRIMER
- K081514 — TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER
- K081705 — LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN
Adverse events under product code EBI
product code EBI- Other
- 1
- Total
- 1
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.