Silmax Contour Carving Block Implant

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K002629 ↗

FDA Product Code

JOF

Device Class

Class II

Regulation

21 CFR Part 874.3620

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Pillar Chin Implant

  Class II

  FDA 510(k) K992239 Active Cleared 22 Nov 1999

• Prolastic Sheeting

  Class II

  FDA 510(k) K954382 Active Cleared 29 Nov 1995

• Pillar Nasal, Dorsal Columella and Nasal Dorsum Implants

  Class II

  FDA 510(k) K992242 Active Cleared 22 Nov 1999

• Scarease Sheets & Scarease Gel

  Class I

  FDA 510(k) K991970 Active Cleared 25 Oct 1999

• Silmax Pectoral Implant

  Class II

  FDA 510(k) K002633 Active Cleared 21 Nov 2000

• Pillar Malar Implant

  Class II

  FDA 510(k) K992240 Active Cleared 22 Nov 1999

• What is the SILMAX Contour Carving Block Implant used for?

  It is a synthetic porous polymer implant used as a space-occupying substance in head and neck reconstructive surgery. Surgeons shape it to conform to patient anatomy for procedures such as augmentation rhinoplasty and tissue defect closures in the esophagus.

• How is the SILMAX implant supplied and intended for use?

  The device is supplied by Pillar Surgical, Inc. and is intended for single use in surgical settings. It is not designed for reuse or resterilization.

• What are the storage requirements for the SILMAX implant?

  The implant is stored at room temperature. It should be kept in its original packaging until the time of use to maintain integrity and sterility.

• Is the SILMAX implant sterile upon delivery?

  While the device data confirms it is supplied for single-use surgical settings, the specific sterilization method is not detailed. It is intended for sterile surgical use as supplied.

• What regulatory classification does the SILMAX implant have?

  It is classified as a Class II device under regulation 874.3620 and was cleared through the FDA 510(k) premarket notification process under k-number K002629.