Cleared Traditional

Pterygoid Indication for GM Helix Implants (K252090) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252090 · JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
163d
Days
Class 2
Risk

K252090 is an FDA 510(k) clearance for the Pterygoid Indication for GM Helix Implants. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. (Curitiba, BR). The FDA issued a Cleared decision on December 12, 2025 after a review of 163 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. devices

Submission Details

510(k) Number K252090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2025
Decision Date December 12, 2025
Days to Decision 163 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 127d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

Straumann USA, LLC
Jennifer Jackson

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 304
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K252090.
NizPlant Dental Implant System
K250476 · Paragon Implant Mfg., LLC · Dec 2025
GEN5™ and GEN5+™ 3.3mmD Dental Implants
K252145 · Paragon Implant Mfg., LLC · Dec 2025
DIMPLO Implant System
K251605 · DIMPLO, Ltd. · Dec 2025
S.I.N. Tapered Pro Conical Zygoma Implant System
K251129 · S.I.N. Implant System Ltda · Nov 2025
GEN5 and GEN5+ Dental Implant System
K251938 · Paragon Implant Mfg., LLC · Oct 2025
HexaPLUS S OneDrill Implant System
K243078 · Osseofuse International, Inc. · Oct 2025