Chrysalis Intelligence · Product Codes · DZE

DZE · Implant, Endosseous, Root-Form

Dental · 227 clearances · 114 unique sponsors

Device class
Class II
Regulation 872.3640
Total clearances
227
2020-01-03 → 2026-06-25
Last 12 months
22
Unique sponsors
114
Medical specialty
Dental
Review panel
DE
Regulation number
872.3640
Implant
Y
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Institut Straumann AG 10 1 2026-03-10
S.I.N. - Sistema DE Implante Nacional S.A. 8 0 2024-07-17
Megagen Implant Co., Ltd. 8 1 2026-06-18
Dentis Co., Ltd. 8 1 2026-03-04
Jjgc Industria E Comercio DE Materiais Dentarios S.A. 8 0 2023-06-23
Dentsply Sirona 8 0 2025-08-21
Arum Dentistry Co., Ltd. 7 0 2025-07-23
Izenimplant Co., Ltd. 6 2 2026-03-16
Innobiosurg Co., Ltd. 6 0 2022-12-20
Southern Implants (Pty), Ltd. 5 0 2024-04-01
Nobel Biocare AB 4 1 2026-02-18
Biomet 3i, LLC 4 0 2025-06-27
Jdentalcare Srl 4 1 2025-09-25
JJGC Indústria e Comércio de Materiais Dentários S.A. 4 1 2025-12-12
Paltop Advanced Dental Solutions, Ltd. 4 1 2025-09-29
Z-Systems AG 3 0 2020-12-01
Biotem Co., Ltd. 3 0 2023-06-24
Keystone Dental, Inc. 3 0 2024-07-09
Paragon Implant Mfg., LLC 3 3 2025-12-23
B.T.I. Biotechnology Institute, Sl. 3 0 2024-10-10
Implant Direct Sybron Manufacturing, LLC 3 0 2023-02-02
Noris Medical , Ltd. 3 0 2025-02-11
S.I.N. Implant System Ltda 3 2 2025-11-07
Truabutment, Inc. 3 0 2025-07-03
Ossvis Co., Ltd. 3 0 2024-11-07
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
D6010 HCPCS High Endosseous root-form dental implant, standard dental implant code
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-06-25 K251188 Uniqa Dental, Ltd. UNIQA® Dental Implants System
2026-06-18 K251232 Megagen Implant Co., Ltd. MegaGen Zygoma Dental Implant System
2026-06-18 K250806 A.B. Dental Devices , Ltd. Dental Implant System
2026-06-17 K260006 Inosys, Inc. INOSS System
2026-05-12 K252731 Promimic AB Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant
2026-03-23 K252031 Adin Dental Implant Systems , Ltd. Adin Long Dental Implant System
2026-03-16 K253334 Izenimplant Co., Ltd. ZENEX Implant System_Short (R-System)
2026-03-10 K252168 Institut Straumann AG Straumann® BLC Implants - Indication Widening
2026-03-04 K253493 Dentis Co., Ltd. Dentis SQ-SL AXEL Fixture
2026-02-18 K252197 Nobel Biocare AB Nobel Biocare S Series Implants
2026-02-02 K252286 Chengdu Besmile Medical Technology Co., Ltd. BIORES Dental Implant System
2026-01-08 K252585 Izenimplant Co., Ltd. ZENEX Implant System_R-System
2025-12-23 K252145 Paragon Implant Mfg., LLC GEN5™ and GEN5+™ 3.3mmD Dental Implants
2025-12-23 K250476 Paragon Implant Mfg., LLC NizPlant Dental Implant System
2025-12-22 K251605 DIMPLO, Ltd. DIMPLO Implant System
2025-12-12 K252090 JJGC Indústria e Comércio de Materiais Dentários S.A. Pterygoid Indication for GM Helix Implants
2025-11-07 K251129 S.I.N. Implant System Ltda S.I.N. Tapered Pro Conical Zygoma Implant System
2025-10-30 K251938 Paragon Implant Mfg., LLC GEN5 and GEN5+ Dental Implant System
2025-10-10 K243078 Osseofuse International, Inc. HexaPLUS S OneDrill Implant System
2025-09-29 K243983 Paltop Advanced Dental Solutions, Ltd. Paltop Dental Implant System
2025-09-26 K251262 S.I.N. Implant System Ltda S.I.N. Dental Implant System
2025-09-25 K251148 Jdentalcare Srl JDEvolution Plus L and JDEvolution Plus LE
2025-08-25 K243834 Nobel Biocare AB NobelZygoma TiUltra Implant system
2025-08-21 K251647 Dentsply Sirona, Inc. MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System
2025-08-18 K250271 JJGC Indústria e Comércio de Materiais Dentários S.A. Neodent Implant System - Zirconia Implant System