Oral-B 5% Sodium Fluoride Varnish— 510(k) K153334
Substantially EquivalentYoung Dental Manufacturing Co. 1, LLC
FDA 510(k) clearance K153334 for Oral-B 5% Sodium Fluoride Varnish, Substantially Equivalent on 2016-05-20. Applicant: Young Dental Manufacturing Co. 1, LLC. Device class: 2.
Clearance details
- Applicant
- Young Dental Manufacturing Co. 1, LLC
- Product code
- Code LBH
- Device class
- Class 2
- Regulation
- 21 CFR 872.3260
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Earth City, MO, US
Recent devices under product code LBH
view allMore clearances from Young Dental Manufacturing Co. 1, LLC
view allRecalls naming K153334
K-number listed on FDA's recall record- Z-1697-2023 — BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish
- Z-0661-2020 — Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensitivity and for the reduction of post-operative sensitivity.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153334.
Data sourced from openFDA. This site is unofficial and independent of the FDA.