DENTEMP ONE STEP— 510(k) K964773
Substantially EquivalentMajestic Drug Co., Inc.
FDA 510(k) clearance K964773 for DENTEMP ONE STEP, Substantially Equivalent on 1997-02-21. Applicant: Majestic Drug Co., Inc.. Device class: 2.
Clearance details
- Applicant
- Majestic Drug Co., Inc.
- Product code
- Code EMA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3275
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bronx, NY, US
Recent devices under product code EMA
view allMore clearances from Majestic Drug Co., Inc.
view allRecalls naming K964773
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K964773.
Data sourced from openFDA. This site is unofficial and independent of the FDA.