Delta Teeth

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

510(k) Number

K831214 ↗

FDA Product Code

ELM

Device Class

Class II

Regulation

21 CFR Part 872.3590

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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• Are Delta Teeth designed for use in specific types of patients, such as children or adults with full or partial dentures?

  Delta Teeth are artificial prosthetic teeth crafted from plastic materials to replicate natural tooth morphology. They are intended for use in removable dentures, which can be either full or partial, depending on clinical needs. The design focuses on functional occlusion and aesthetic integration within dental prosthetics, making them suitable for adult patients requiring dentures. There is no specific indication in the records for pediatric use or partial dentures, so their applicability should be determined by the dentist or dental laboratory based on patient-specific requirements.

• How are Delta Teeth supplied, and can they be reused or are they single-use?

  Delta Teeth are supplied as components for use in dental laboratories or clinical settings where dentures are fabricated. The records indicate they can be supplied as either single-use or reusable, depending on the clinical protocol followed. Reusability would depend on proper cleaning, sterilization, and maintenance procedures to ensure safety and functionality. Clinicians should follow established protocols to determine the appropriate use case for their practice.

• Are there different sizes or models of Delta Teeth available, and how do I determine which one to use?

  Delta Teeth come in multiple sizes and models, as indicated by the extensive list of registration numbers in the records. These variations likely correspond to different tooth shapes, sizes, and possibly anatomical positions (e.g., incisors, molars) to accommodate various denture designs. The selection of a specific size or model should be based on the patient’s dental anatomy, the dentist’s prescription, and the specific requirements of the denture being fabricated. Consulting with a dental technician or dentist is recommended to ensure proper fit and function.

• What storage conditions should be followed for Delta Teeth to maintain their integrity?

  The records do not specify detailed storage conditions for Delta Teeth, such as temperature or humidity requirements. However, as plastic prosthetic components, they should generally be stored in a clean, dry environment to prevent contamination or degradation. If stored for extended periods, they should be kept in their original packaging or a sealed container to avoid exposure to dust, moisture, or direct sunlight. Always follow manufacturer guidelines or best practices for dental materials to ensure optimal performance.

• What is the regulatory pathway for Delta Teeth, and how was their clearance determined?

  Delta Teeth received FDA 510K clearance (K831214) in 1983 under the Dental advisory committee (DE) and were classified as substantially equivalent to a predicate device. The clearance was granted through a traditional 510(k) review process, which means the manufacturer demonstrated that the device was at least as safe and effective as a legally marketed predicate device. The product falls under FDA regulation 872.3590 and is categorized under product code ELM for Denture, Plastic, Teeth. This pathway ensures compliance with FDA standards for dental prosthetics.