510(k) Clearances
See how Enerxen has helped medtech innovators secure market access through expert regulatory support
Selected 510(k) Success Stories
Enerxen specializes in guiding medical device manufacturers through the complex 510(k) submission process. Our track record includes numerous cleared devices across multiple specialties—helping clients achieve faster time-to-market with confidence and compliance.
K240982 – DESS Dental Smart Solutions
- Device Type / Classification: Abutment, Implant, Dental, Endosseous — Class II device under FDA Regulation 872.3630 (Product Code: NHA, PHP)
- Clearance Date: August 26, 2024
- Applicant: Terrats Medical SL (Barcelona, Spain) — Enerxen Consulting, Inc. (Montreal, Canada) served as the FDA Correspondent
- Key Challenge Overcome: expanded PNP digital dentistry workflow to include many ceramic materials, scanners, milling machines, and CAM software.
- Submission Type & Review Details: Traditional 510(k), direct clearance (no Third‑Party review), through Enerxen as FDA Correspondent
- Timeline: 139 calendar days from submission
- Device Type / Classification: Abutment, Implant, Dental, Endosseous — Class II device under FDA Regulation 872.3630 (Product Code: NHA, PHP)
- Clearance Date: May 22, 2025
- Applicant: Terrats Medical SL (Barcelona, Spain) — Enerxen Consulting, Inc. (Montreal, Canada) served as the FDA Correspondent
- Key Challenge Overcome: expanded PNP digital dentistry workflow to include many ceramic materials, scanners, milling machines, and CAM software.
- Submission Type & Review Details: Traditional 510(k), direct clearance (no Third‑Party review), through Enerxen as FDA Correspondent
- Timeline: 92 calendar days from submission
Ready to Bring Your Device to Market?
Whether you’re preparing your first 510(k) or refining your regulatory approach, Enerxen is here to help. Let’s talk.