Variable Parallel Pin

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K973521 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Spline Dental Implant System - Spline XI Implant

  Class II

  FDA 510(k) K981562 Active Cleared 30 Jul 1998

• Edosseous Dental Implant

  Class II

  FDA 510(k) K970127 Active Cleared 23 Jun 1997

• Spline Dental Implant System-Temporary Abutment

  Class II

  FDA 510(k) K982305 Active Cleared 22 Sep 1998

• Temporary Gingival Cuff And Impression Post And Implant Analog

  Class II

  FDA 510(k) K001786 Active Cleared 21 Jun 2000

• Threadloc Dental Implant Systems

  Class II

  FDA 510(k) K964768 Active Cleared 25 Feb 1997

• Spline Engaging Shouldered Abutment System

  Class II

  FDA 510(k) K970752 Active Cleared 23 Jun 1997

See all devices from Sulzer Calcitek, Inc. →

• What is the Variable Parallel Pin used for in dental implant procedures?

  The Variable Parallel Pin is a surgical guide designed to evaluate and ensure parallelism, prosthetic fit, and proper spacing between dental implants and adjacent natural teeth. By providing a visual reference during surgery, it helps clinicians achieve precise implant placement, which is critical for the stability and success of subsequent prosthetic components. This reduces the risk of misalignment or incorrect spacing, improving long-term outcomes for patients.

• Is the Variable Parallel Pin supplied sterile, and how should it be prepared for use?

  The Variable Parallel Pin is not sterile at the time of shipment. It is intended for reuse and must be sterilized prior to each use following standard dental surgical protocols. Sterilization ensures patient safety by eliminating contaminants and maintaining the instrument’s integrity for accurate implant alignment.

• What type of regulatory clearance does the Variable Parallel Pin hold?

  The Variable Parallel Pin holds FDA 510(k) clearance under the classification of Dental (DE) advisory committee. The clearance (K973521) was granted in 1997, confirming its substantial equivalence to a predicate device. This regulatory pathway ensures the device meets safety and effectiveness standards for dental surgical use.

• Can the Variable Parallel Pin be used in MRI environments?

  The available data does not provide specific MRI safety information for the Variable Parallel Pin. Clinicians should verify compatibility with their MRI equipment and protocols before use in magnetic resonance imaging environments to avoid potential risks.

• How does the Variable Parallel Pin improve the accuracy of dental implant placement?

  The Variable Parallel Pin enhances accuracy by offering a visual guide to assess the alignment and spacing of dental implants relative to adjacent teeth. This ensures implants are positioned optimally for prosthetic components, reducing the likelihood of complications such as misalignment or improper fit. Precise placement improves the stability and longevity of the final restoration.