Branemark System
by Nobelpharma USA, Inc. 510(k)
Active
510(k) K934825
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK934825 | Date8 Aug 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DZE
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3640
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Branemark System is a dental implant device designed for osseointegrated fixation in the jawbone, enabling the placement of prosthetic teeth. It consists of titanium components intended to integrate with living bone, providing a stable foundation for dental restoration.
This system is supplied as a sterile, single-use or reusable implant assembly, regulated under FDA 510(k) clearance (K934825) for dental applications. It is intended for use in oral and maxillofacial surgery settings, with components available in standardized sizes for patient-specific applications. Compliance with dental implant standards ensures compatibility with prosthetic abutments and crowns.
Other devices from Nobelpharma USA, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of clinical settings is the Branemark System intended for use in?
The Branemark System is designed specifically for oral and maxillofacial surgery environments. Its titanium components are engineered for osseointegration in the jawbone, making it suitable for procedures where stable dental implants are required to support prosthetic teeth.
Is the Branemark System available in multiple sizes, and how does that benefit patients?
Yes, the Branemark System comes in standardized sizes tailored for patient-specific applications. This ensures compatibility with individual anatomical variations, allowing for precise placement and optimal integration with the jawbone to support prosthetic abutments and crowns.
How is the Branemark System supplied, and what does that mean for clinical workflow?
The Branemark System is supplied as either a sterile, single-use or reusable implant assembly. This flexibility allows clinicians to choose based on their facility’s protocols, infection control needs, and cost considerations, ensuring compliance with dental implant standards while maintaining workflow efficiency.
What regulatory pathway does the Branemark System follow, and what does that imply for its use?
The Branemark System follows the FDA’s 510(k) clearance pathway, specifically under K934825, with a decision classified as ‘Substantially Equivalent’ to prior dental implant devices. This implies it meets established safety and performance standards for dental implants, ensuring its use aligns with regulatory expectations for osseointegrated fixation in the jawbone.