Consulting Wallah › Device Explorer › Orthopaedic implants › Screw endosteal dental implant, one-piece
Device Explorer · FDA GUDID · GMDN 55848

Screw endosteal dental implant, one-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 devices3,981in commercial distribution
Companies46labelers on GUDID
Single‑use100%of device records
Sterile88%labelled sterile
Prescription93%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Sin Sistema De Implante Nacional S/A65516%
Jjgc Indústria E Comércio De Materiais Dentários S/A.52413%
Kjmeditech.Co.,Ltd48812%
Ace Surgical Supply Co., Inc.44611%
Cortex - Dental Implants Industries Ltd1955%
Osstem Implant Co., Ltd.1624%
Ot Medical Gmbh1514%
Soadco, S.L.1444%

Top labelers

CompanyDevicesShare
Sin Sistema De Implante Nacional S/A65516%
Jjgc Indústria E Comércio De Materiais Dentários S/A.52413%
Kjmeditech.Co.,Ltd48812%
Ace Surgical Supply Co., Inc.44611%
Cortex - Dental Implants Industries Ltd1955%
Osstem Implant Co., Ltd.1624%
Ot Medical Gmbh1514%
Soadco, S.L.1444%
Henry Schein, Inc.1353%
Achimhai Medical Corporation832%
Park Dental Research Corp822%
Simpler Implant Solutions Inc712%

Company = labeler of record on GUDID. 46 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DENTIN ONE PIECE IMPLANTSSaturn (Premium)Dynamix Hex (Premium)Classix Hex (Premium)Smart One PieceSaturn (Prime)Dynamix Conical (Prime)Classix Conical (Prime)Dynamix Hex (Prime)Classix Hex (Prime)Magix (Prime)MAGIX Dental Implant Ø4.2 L10mm PrimeTRITRI-NTRX-TPTRX-OP

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-Form2,523
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM1,015
NHAAbutment, Implant, Dental, Endosseous357
NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS303
DZEImplant, endosseous, root-form78
OATImplant, Endosseous, Orthodontic27

GMDN & GCC registration

  • GMDN code 55848 · implantable
  • Single‑use 100% · sterile 88% · Rx‑only 93% · 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) · 740Outer Diameter (Millimeter) · 676Width (Millimeter) · 342Height (Millimeter) · 79Lumen/Inner Diameter (Millimeter) · 40Depth (Millimeter) · 9

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

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

3,981 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Screw endosteal dental implant, one-piece", from 46 companies. The largest labeler is Sin Sistema De Implante Nacional S/A with 16% of records.

Which FDA product codes apply?

DZE (Implant, Endosseous, Root-Form), DZE (IMPLANT, ENDOSSEOUS, ROOT-FORM), NHA (Abutment, Implant, Dental, Endosseous), NHA (ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS)

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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