Transcend— 510(k) K201795
Substantially EquivalentUltradent Product, Inc.
FDA 510(k) clearance K201795 for Transcend, Substantially Equivalent on 2020-09-28. Applicant: Ultradent Product, Inc.. Device class: 2.
Clearance details
- Applicant
- Ultradent Product, Inc.
- Product code
- Code EBF
- Device class
- Class 2
- Regulation
- 21 CFR 872.3690
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- South Jordan, UT, US
Recent devices under product code EBF
view allMore clearances from Ultradent Product, Inc.
view allRecalls naming K201795
K-number listed on FDA's recall record- Z-3067-2024 — Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61% filled by volume and has an average particle size of 0.9 ¿m (by weight) with narrow upper limit particle distribution. Component: N/A
- Z-3068-2024 — Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61% filled by volume and has an average particle size of 0.9 ¿m (by weight) with narrow upper limit particle distribution. Component: N/A
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201795.
Data sourced from openFDA. This site is unofficial and independent of the FDA.