Consulting Wallah › Device Explorer › Orthopaedic implants › Screw endosteal dental implant, two-piece
Device Explorer · FDA GUDID · GMDN 55849

Screw endosteal dental implant, two-piece

A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e

US‑registered devices28,719in commercial distribution
Companies90labelers on GUDID
Single‑use99%of device records
Sterile72%labelled sterile
Prescription83%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Ossvis Co., Ltd.6,19022%
Hiossen, Inc.2,5799%
Osstem Implant Co., Ltd.2,1517%
Dentis Co. ,Ltd1,3885%
Megagen Implant Co. Ltd1,1724%
Southern Implants (Pty) Ltd9513%
Zimvie Us Corp Llc8933%
Institut Straumann Ag8773%

Top labelers

CompanyDevicesShare
Ossvis Co., Ltd.6,19022%
Hiossen, Inc.2,5799%
Osstem Implant Co., Ltd.2,1517%
Dentis Co. ,Ltd1,3885%
Megagen Implant Co. Ltd1,1724%
Southern Implants (Pty) Ltd9513%
Zimvie Us Corp Llc8933%
Institut Straumann Ag8773%
Ritter Implants Gmbh & Co. Kg8013%
Emery Enterprises Inc7082%
Kjmeditech.Co.,Ltd5012%
Izenimplant Co., Ltd.4902%

Company = labeler of record on GUDID. 90 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DS OmniTaperDS PrimeTaperAstra Tech Implant System®Astra Tech Implant System® EVANKYLOS®ASTRA TECH Implant System® EVASTRA TECH Implant System®NobelReplace® S TiUnite®NobelParallel™ S TiUnite®NobelActive® S TiUnite®NobelReplace® S TiUltra™NobelParallel™ S TiUltra™NobelActive® S TiUltra™NobelZygoma™ TiUltra™Nobel Biocare N1™NobelZygoma™

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
DZEImplant, Endosseous, Root-Form17,610
NHAAbutment, Implant, Dental, Endosseous9,765
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM5,386
DZEImplant, endosseous, root-form404
NDPAccessories, Implant, Dental, Endosseous98
JEYPlate, Bone25

GMDN & GCC registration

  • GMDN code 55849 · implantable
  • Single‑use 99% · sterile 72% · Rx‑only 83% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Millimeter) · 4,716Outer Diameter (Millimeter) · 4,037Height (Millimeter) · 319Angle (degree) · 164Lumen/Inner Diameter (Millimeter) · 118Width (Millimeter) · 7

Use these as the dimensions to specify in a tender line.

How many screw endosteal dental implant, two-piece products are registered in the US?

28,719 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Screw endosteal dental implant, two-piece", from 90 companies. The largest labeler is Ossvis Co., Ltd. with 22% of records.

Which FDA product codes apply?

DZE (Implant, Endosseous, Root-Form), NHA (Abutment, Implant, Dental, Endosseous), DZE (IMPLANT, ENDOSSEOUS, ROOT-FORM), DZE (Implant, endosseous, root-form)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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