Symbioceram
510(k) K990629
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK990629 | Date19 Mar 1999 | 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- Withdrawn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
- EIH
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.6660
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
Symbioceram Dental Porcelain is a dental porcelain material classified under product code EIH, intended for use in fabricating porcelain-fused-to-metal (PFM) restorations. It is designed to be applied to metal substructures to create dental crowns or bridges, serving as a restorative material in dental laboratory settings. The material is engineered to meet the requirements of dental porcelain systems used in fixed prosthodontics.
This dental porcelain is supplied for use by dental laboratory technicians and is intended for single-use applications in the fabrication of PFM restorations. It is regulated under FDA 510(k) clearance (K990629) and falls under the Traditional 510(k) review pathway. The material is not described as sterile or reusable, and no MRI safety information is provided. Storage conditions are not specified in the available data.
Other devices from Ney Dental, Inc.
Questions
AI-generated answers, 20 Sep 2026
What types of dental restorations can Symbioceram be used to create, and who is it intended for in the clinical setting?
Symbioceram is specifically designed for fabricating porcelain-fused-to-metal (PFM) restorations, such as dental crowns and bridges. It is intended exclusively for use by dental laboratory technicians in laboratory settings, not for direct clinical application by dentists or patients.
Is Symbioceram meant for single-use or reusable applications, and how does that affect its handling?
Symbioceram is intended for single-use in the fabrication of PFM restorations. Since it is not reusable, each batch or application should be treated as non-reusable, and proper disposal protocols should follow dental laboratory waste guidelines. There is no indication it is sterile, so it should not be used in sterile clinical procedures.
What regulatory pathway does Symbioceram follow, and how does that affect its use in dental practices?
Symbioceram is cleared under the FDA’s 510(k) Traditional Review pathway (K990629) and is classified under product code EIH for dental porcelain systems. This means it has been determined substantially equivalent to a legally marketed predicate device, ensuring compliance with U.S. dental material regulations. Clinicians should confirm local state or practice-specific requirements, but the FDA clearance indicates it meets established safety and effectiveness standards for PFM restorations.
Are there any special storage instructions for Symbioceram, or can it be stored under standard dental laboratory conditions?
The provided data does not specify exact storage conditions for Symbioceram. However, as with most dental porcelain materials, it should be stored in a cool, dry place, protected from moisture and extreme temperatures. Since it is not described as sterile, it should not be stored in a sterile environment unless the manufacturer’s instructions (not provided here) explicitly state otherwise.