Sr Phonares II
510(k) K120736
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK120736 | Date14 May 2012 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ELM
- FDA applicant
- Ivoclar Vivadent, AG
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3590
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The SR Phonares II is a composite material-based ready-made denture tooth system designed for use in complete and partial dentures. Classified as a plastic denture tooth, it provides aesthetic and durable prosthetic solutions for patients requiring removable dental restorations. The system includes anterior teeth and posterior teeth with two occlusal designs: classic (SR Phonares II Typ) and lingualized (SR Phonares II Lingual).
SR Phonares II is supplied as a non-sterile, single-use dental prosthetic component intended for use in dental laboratories. The teeth are compatible with standard denture base materials and are regulated under FDA classification II (510(k) clearance K120736). Storage requires protection from moisture and extreme temperatures, and the system adheres to regulatory requirements outlined in 21 CFR 872.3590. No MRI safety considerations are specified.
From the manufacturer
Enhance the quality of removable prosthetics with SR Phonares II from Ivoclar. Ready-made teeth made of composite material for aesthetic, durable solutions.
SR Phonares II are composite ready-made teeth designed for complete dentures and partial dentures. The tooth line comprises the SR Phonares II anterior composite teeth, as well as the posterior composite teeth SR Phonares II Typ for classic occlusal designs and the SR Phonares II Lingual for lingualized occlusal designs.
Other devices from Ivoclar Vivadent AG
Questions
AI-generated answers, 18 Sep 2026
What types of dentures is the SR Phonares II system designed for, and how does it differ between anterior and posterior teeth?
The SR Phonares II is specifically designed for use in complete and partial dentures, providing a ready-made prosthetic solution for removable dental restorations. It includes both anterior (front) teeth and posterior (back) teeth, with two distinct occlusal (biting surface) designs: the classic (SR Phonares II Typ) and the lingualized (SR Phonares II Lingual). The lingualized design is optimized for a more natural, functional bite alignment, while the classic design offers a traditional aesthetic. Both are compatible with standard denture base materials.
Is the SR Phonares II system single-use or reusable, and what storage conditions are required?
The SR Phonares II is non-sterile and intended for single-use in dental laboratories. To maintain integrity, it must be stored in a dry environment, protected from moisture and extreme temperatures. Proper storage ensures the composite material retains its durability and aesthetic properties for optimal use in denture fabrication.
How is the regulatory status of this device determined, and what does the FDA classification mean for dental professionals?
The SR Phonares II holds FDA 510(k) clearance (K120736) under classification II, meaning it was deemed substantially equivalent to a legally marketed predicate device through a traditional review process. This classification indicates it meets FDA safety and effectiveness standards for plastic denture teeth (regulated under 21 CFR 872.3590) and is suitable for use in complete or partial dentures as a prosthetic component. The clearance does not imply clinical indications but confirms regulatory compliance for dental laboratory use.
Are there multiple sizes or models available for the SR Phonares II system, and how do they relate to patient-specific needs?
While the exact sizing details are not specified in the data, the SR Phonares II system includes multiple registration numbers (e.g., 3009541709, 3010872423, etc.), which likely correspond to various tooth sizes, shapes, or occlusal designs (e.g., classic vs. lingualized). These variations allow dental laboratories to select teeth that best match a patient’s anatomical requirements, bite alignment, and aesthetic preferences for complete or partial dentures. Consult the manufacturer’s sizing guides for precise matching.