JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD
FDA 510(k) clearance K100653 · decided 2010-10-08
Clearance details
- K-number
- K100653
- Device name
- JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD
- Applicant
- Lang Dental Mfg. Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-03-08
- Decision date
- 2010-10-08
- Days to decision
- 214 days
- Clearance type
- Traditional
- Product code
- EBI
- Device class
- 2
- Regulation number
- 872.3760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Wheeling, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.