APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)— 510(k) K260830
Substantially EquivalentSangi Co., Ltd.
FDA 510(k) clearance K260830 for APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste), Substantially Equivalent on 2026-03-18. Applicant: Sangi Co., Ltd.. Device class: 2.
Summary
Sangi's APAPRO Desensitizer Homecare is filed under LBH, cavity varnishes. The record's device name adds "Remineralizing Anti-sensitivity Toothpaste" in parentheses, and the record doesn't describe the product beyond that name and code name.
Class II, 21 CFR 872.3260. It was a Traditional 510(k), and Dental is both the classification panel and the review panel.
Sangi filed from Tokyo, Japan. The decision came 5 calendar days after FDA received it (March 13 to March 18, 2026). The record flags it as a third-party review.
Clearance details
- Applicant
- Sangi Co., Ltd.
- Product code
- Product 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
- Tokyo, JP
Recent devices under product code LBH
view allMore clearances from Sangi Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.