Algi-Band

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

510(k) Number

K951237 ↗

FDA Product Code

ELW

Device Class

Class II

Regulation

21 CFR Part 872.3660

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Dent-Temp Acrylic

  Class II

  FDA 510(k) K972198 Active Cleared 17 Dec 1997

• Hema-Benz

  Class II

  FDA 510(k) K953405 Active Cleared 27 Sep 1995

• Vila

  Class II

  FDA 510(k) K951381 Active Cleared 27 Apr 1995

• Giroc

  Class II

  FDA 510(k) K951235 Active Cleared 20 Apr 1995

• Hema-Glu

  Class II

  FDA 510(k) K951220 Active Cleared 12 May 1995

• Pro-Lock

  Class II

  FDA 510(k) K951236 Active Cleared 18 Apr 1995

See all devices from Health-Dent Intl., Inc. →

• Is the Algiband designed for single-use or can it be reused across multiple patients?

  The Algiband is intended for single-patient use per impression cycle to ensure sterility and precision. While the material itself is reusable within a dental office or clinic, it must be dedicated to one patient at a time to maintain clinical safety and accuracy.

• How is the Algiband sterilized and prepared for use in a dental office?

  The Algiband is supplied as a reusable material, but its sterility is ensured per single-patient use during an impression cycle. The manufacturer’s instructions (not provided here) would outline the sterilization process, but typically, dental impression materials like this are cleaned and sterilized between uses to prevent cross-contamination.

• What regulatory pathway was followed for the FDA clearance of the Algiband, and what does that mean for its use?

  The Algiband received FDA 510(k) clearance (K951237) under the traditional review process, with a decision of *Substantially Equivalent* to a predicate device. This means it was determined to have the same intended purpose and technological characteristics as a previously cleared dental impression material, ensuring compliance with 21 CFR 872.3660 for dental impression devices.

• Are there different sizes or models of the Algiband available, and how would I know which one to select?

  The provided data does not specify distinct sizes or models of the Algiband, but it is classified under product code ELW for dental impression materials. Selection would depend on the manufacturer’s guidelines (e.g., patient age, arch size, or specific orthodontic needs), which would likely be detailed in the accompanying product literature or catalog.

• How should the Algiband be stored to maintain its integrity and usability?

  While exact storage instructions aren’t detailed here, reusable dental impression materials like the Algiband typically require clean, dry storage in a sealed container to prevent contamination or degradation. The manufacturer’s instructions would specify environmental conditions (e.g., temperature, humidity) to preserve its properties for repeated use.