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510(k) Data Aggregation
K Number
K192033Device Name
Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip
Manufacturer
Bennett Jacoby, DDS, MS, Inc.
Date Cleared
2020-06-09
(315 days)
Product Code
DZI, ELC
Regulation Number
872.4120Why did this record match?
Applicant Name (Manufacturer) :
Bennett Jacoby, DDS, MS, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Contour P-Insert System (CPIS) is an accessory attachment to the Dmetec Surgystar piezosurgery system. It is used by dental professionals during treatment of periodontal disease and oral surgery for the following intended uses:
1. Surgical procedures including osteotomy, osteoplasty, periodontal surgery and implantation.
2. Soft tissue debridement and removal, particularly in intrabony lesions.
Device Description
The Contour P-Insert System (CPIS) is an accessory to the Dmetec Surgystar Piezosurgery System (DSPS). The CPIS comprises two sets of components. CPIS tips and CPIS shafts, as follows:
- CPIS Shafts: The two CPIS shaft models (45 and 90) are machined from 431 stainless steel. Both models ● have an identical female threaded proximal end that is designed and configured to attach to the DSPS handpiece distal male threaded end. On the shafts' distal end, both models have an identical male threaded section that is designed and configured to attach the various models of CPIS tips. These models
45 and 90 differ primarily in that the CPIS 45 has a mid-shaft bend of 20.59 while the CPIS 90 does not.
- CPIS Tips: The three CPIS tip models (Tri, WC and QT) are machined from PEEK ● (polyetheretherketone). All three tip models have an identical female unthreaded hole on the proximal end that is designed and configured to attach to the distal male threaded end of the CPIS shafts. These tips have different grooves, edges and vertices that abrade, ablate, cut and recontour oral tissues as intended by the operator.
- CPIS Inserts: The CPIS inserts are created by the end user by attaching one CPIS tip to one CPIS shaft. By combining each of the three tip models with each of the two shafts models, six versions of CPIS insert can thus be created, depending on the clinical needs and professional judgement of the end-user. These resultant CPIS inserts are designated as follows: CPIS 45/WC, CPIS 45/QT, CPIS 90/Tri, CPIS 90/WC and CPIS 90/QT. The CPIS inserts are attached to the DSPS using the DSPS torque wrench.
During use by the end user, the DSPS is powered, generating high frequency mechanical micro-vibrations in the handpiece, that is transmitted to the CPIS insert. The tip sides and tip end of the CPIS inserts are brought into contact with the patient's various oral tissue types to accomplish dental procedures where ablation, abrasion, cutting and/or recontouring of the target tissue is desired.
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