# K973521: Variable Parallel Pin

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Calcitek, Inc.
- Decided: Nov 20, 1997 after 64 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Sulzer Calcitek's Parallel Pins: named in the summary without a submission number
- (no number) Nobelpharma BRANEMARK SYSTEM® Abutment Selection Kit: named in the summary without a submission number

## Indications for use
The Variable Parallel Pin is indicated for use in evaluating angles up to 25 degrees and to gauge implant spacing and fit of prosthetics with flare diameters 6.5mm or less between implants and adjacent natural teeth.

Source page: https://510kreport.com/device/K973521
Methodology: https://510kreport.com/methodology