Omnisil, Vinyl Polysiloxane Impression Material

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

510(k) Number

K881091 ↗

FDA Product Code

ELW

Device Class

Class II

Regulation

21 CFR Part 872.3660

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Occlusin Light Cured Visible Radiopaque Composite

  Class II

  FDA 510(k) K844326 Active Cleared 3 Dec 1984

• Audi-Sil Earmold Material

  Class II

  FDA 510(k) K771615 Active Cleared 30 Aug 1977

• Opalux Visible Light Cured Anterior Composite

  Class II

  FDA 510(k) K863882 Active Cleared 18 Nov 1986

• Tripton(Tm) Visible Light-Cured Univ. Bonding

  Class II

  FDA 510(k) K885010 Active Cleared 13 Feb 1989

• Putty, Accoe

  Class II

  FDA 510(k) K760225 Active Cleared 21 Jul 1976

• Medical Exam Table

  Class I

  FDA 510(k) K830294 Active Cleared 11 Jan 1984

See all devices from Coe Laboratories, Inc. →

• What is Omnisil Vinyl Polysiloxane Impression Material used for?

  Omnisil is intended for use in dental applications as an impression material. It is a vinyl polysiloxane (VPS) formulation designed to capture detailed oral anatomy for dental prosthetics, restorations, and orthodontic appliances, based on its classification and clearance for dental use.

• How is Omnisil supplied and is it sterile or single-use?

  Omnisil is supplied by Coe Laboratories, Inc. as a non-sterile, single-use dental impression material. It is not provided in sterile packaging and is intended for one-time use per patient to prevent cross-contamination, consistent with standard dental impression materials.

• What regulatory pathway was used for Omnisil and when was it cleared?

  Omnisil was cleared through the FDA 510(k) process under submission K881091 on June 28, 1988, as a substantially equivalent device. It is classified as a Class II medical device with product code ELW and regulation number 872.3660.