FDA.reportPublic FDA data

S200EML (Contra) Dental Surgery Hand Piece

Primary DI
00810126043160
Brand
S200EML (Contra) Dental Surgery Hand Piece
Company
HIOSSEN, INC.
Model
CA13030007
Device description
S200EML (Contra) is intended for use in dental oral surgery and dental implant. The dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.
Published
2026-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBWController, Foot, Handpiece And Cord
EGSHandpiece, Contra- And Right-Angle Attachment, Dental
KMWHandpiece, Rotary Bone Cutting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBWController, Foot, Handpiece And CordDental1
EGSHandpiece, Contra- And Right-Angle Attachment, DentalDental1
KMWHandpiece, Rotary Bone CuttingDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810126043160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810126043160008101260431608101260431600810126043160

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
796083090
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810125998713ET Scan Healing AbutmentETSHA404MTH2026-09-04
00810125998720ET Scan Healing AbutmentETSHA404RTH2026-09-04
00810125998737ET Scan Healing AbutmentETSHA405MTH2026-09-04
00810125998744ET Scan Healing AbutmentETSHA405RTH2026-09-04
00810125998751ET Scan Healing AbutmentETSHA407MTH2026-09-04
00810125998768ET Scan Healing AbutmentETSHA407RTH2026-09-04
00810125998775ET Scan Healing AbutmentETSHA409MTH2026-09-04
00810125998782ET Scan Healing AbutmentETSHA409RTH2026-09-04
00810125998799ET Scan Healing AbutmentETSHA454MTH2026-09-04
00810125998805ET Scan Healing AbutmentETSHA454RTH2026-09-04
00810125998812ET Scan Healing AbutmentETSHA455MTH2026-09-04
00810125998829ET Scan Healing AbutmentETSHA455RTH2026-09-04
00810125998836ET Scan Healing AbutmentETSHA457MTH2026-09-04
00810125998843ET Scan Healing AbutmentETSHA457RTH2026-09-04
00810125998850ET Scan Healing AbutmentETSHA459MTH2026-09-04
00810125998867ET Scan Healing AbutmentETSHA459RTH2026-09-04
00810125998874ET Scan Healing AbutmentETSHA504RTH2026-09-04
00810125998881ET Scan Healing AbutmentETSHA505RTH2026-09-04
00810125998898ET Scan Healing AbutmentETSHA507RTH2026-09-04
00810125998904ET Scan Healing AbutmentETSHA509RTH2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00366975072108SterlingBENCO DENTAL SUPPLY CO.EGS2026-08-27
00366975072115SterlingBENCO DENTAL SUPPLY CO.EGS2026-08-27
00366975069252SterlingBENCO DENTAL SUPPLY CO.EBW2026-07-14
00366975069276Sterling Surgical Motor Main ConsoleBENCO DENTAL SUPPLY CO.EBW2026-07-14
00366975069283SterlingBENCO DENTAL SUPPLY CO.EBW2026-07-14
00366975069290SterlingBENCO DENTAL SUPPLY CO.EBW2026-07-14
00366975069306SterlingBENCO DENTAL SUPPLY CO.EBW2026-07-14
J021304950011Foot control S-NW3W & H Dentalwerk Bürmoos GmbHEBW2026-06-23
J021304970001Foot control S-N3W & H Dentalwerk Bürmoos GmbHEBW2026-06-23
J021305040001Implantmed Plus II (SI-2100)W & H Dentalwerk Bürmoos GmbHEBW2026-06-23
J021305050001Implantmed Plus II (SI-2101)W & H Dentalwerk Bürmoos GmbHEBW2026-06-23
J021305060001Implantmed Plus II (SI-2102)W & H Dentalwerk Bürmoos GmbHEBW2026-06-23
J021305070001Piezomed Module Plus II (SP-210 M)W & H Dentalwerk Bürmoos GmbHEBW2026-06-23
04589551395088Multi Pad2NAKANISHI INC.EBW2026-06-02
D77142130771Dental CityICP, INC.EGS2026-05-27
D77142131771Dental CityICP, INC.EGS2026-05-27
D77142132771Dental CityICP, INC.EGS2026-05-27
D77142133771Dental CityICP, INC.EGS2026-05-27
10304040196974Henry ScheinHENRY SCHEIN, INC.EGS2026-05-14
10304040196981Henry ScheinHENRY SCHEIN, INC.EGS2026-05-14
08033837935889AnthosCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935896AnthosCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935902Stern WeberCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935919Stern WeberCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935926CastelliniCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935933CastelliniCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08809260475519X-CUBESaeshin Precision Co., Ltd.EBW2026-04-02
08809260470279TRAUSSaeshin Precision Co., Ltd.EGS2026-03-31
08809260475403AHP-85-SSSaeshin Precision Co., Ltd.EBW2026-03-25
08809260475410TRAUSSaeshin Precision Co., Ltd.EBW2026-03-25