ORTHO-JET CRYSTAL— 510(k) K112397
Substantially EquivalentLang Dental Mfg. Co., Inc.
FDA 510(k) clearance K112397 for ORTHO-JET CRYSTAL, Substantially Equivalent on 2011-11-04. 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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- 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.