Vident 90 Alloy and Vident 95 Alloy

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K903008 ↗

FDA Product Code

EJH

Device Class

Class II

Regulation

21 CFR Part 872.3710

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Vita Titanium Porcelain

  Class II

  FDA 510(k) K982664 Active Cleared 2 Aug 1998

• Vita Response

  Class II

  FDA 510(k) K000597 Active Cleared 17 May 2000

• V.R.S. Denture Resin Material

  Class II

  FDA 510(k) K962333 Active Cleared 7 Aug 1996

• In-Ceram Spinell

  Class II

  FDA 510(k) K951183 Active Cleared 2 May 1995

• Vita Vm 7, Model NX77 Xxxx, NX78XXXX, NX79 Xxxx; Vita Vm 8, Model VX60 Xxxx, VX61 Xxxx, VX62 Xxxx; Vita Vm 9, Model NX98

  Class II

  FDA 510(k) K060441 Active Cleared 27 Apr 2006

• Vita Pm 7 (20 Gram Bottles), Vita Pm 7 (50 Gram Bottles)

  Class II

  FDA 510(k) K050362 Active Cleared 15 Mar 2005

See all devices from Vident →

• What are the Vident 90 and 95 Alloy dental base metal alloys used for?

  The Vident 90 and 95 Alloy dental base metal alloys are specifically designed for dental restorative applications, including crowns, bridges, and other fixed dental prosthetics. Their primary purpose is to provide durable structural integrity while maintaining biocompatibility for long-term use within the oral cavity. These alloys are engineered to meet the demands of professional dental laboratories for fabricating reliable restorations.

• Are the Vident 90 and 95 Alloy alloys single-use or reusable?

  The Vident 90 and 95 Alloy dental base metal alloys are intended for reusable use in dental laboratories. They are not pre-sterilized or labeled as single-use, meaning they can be processed and reused multiple times under proper laboratory conditions. This makes them cost-effective for fabricating multiple restorations over time.

• What regulatory approvals do the Vident 90 and 95 Alloy alloys have?

  The Vident 90 and 95 Alloy dental base metal alloys hold FDA 510(k) clearance under the classification of Class II dental devices (product code EJH). This clearance confirms they meet U.S. regulatory standards for safety and effectiveness as dental restorative materials. The submission was reviewed by the FDA’s Dental Devices Advisory Committee and determined to be substantially equivalent to a predicate device.

• How should these alloys be stored before use in a dental lab?

  While the provided data does not specify exact storage conditions, dental base metal alloys like the Vident 90 and 95 Alloy should generally be stored in a clean, dry environment to prevent contamination or degradation. They should be kept in their original packaging until ready for use, away from direct sunlight, extreme temperatures, and sources of moisture or corrosion. Proper handling ensures the alloys retain their structural integrity and biocompatibility for restorative work.

• Are there different models or variations of the Vident 90 and 95 Alloy alloys?

  The Vident 90 and 95 Alloy refer to two distinct formulations of dental base metal alloys, differentiated by their alloy composition (90% and 95% base metal content, respectively). While both serve the same primary purpose—fabricating dental restorations—their varying compositions may influence properties like hardness, corrosion resistance, or casting behavior. No additional model numbers or variations are mentioned beyond these two alloys in the provided data.