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
00810126045911ET IV Fixture Ultra-Wide NH Regular Pre-MountedAET4R6015B2026-04-10
00810126045294ET IV Fixture NH Regular Pre-MountedAET4M3508B2026-04-07
00810126045300ET IV Fixture SA Regular Pre-MountedAET4M3508S2026-04-07
00810126045317ET IV Fixture NH Regular Pre-MountedAET4M3510B2026-04-07
00810126045324ET IV Fixture SA Regular Pre-MountedAET4M3510S2026-04-07
00810126045331ET IV Fixture NH Regular Pre-MountedAET4M3511B2026-04-07
00810126045348ET IV Fixture SA Regular Pre-MountedAET4M3511S2026-04-07
00810126045355ET IV Fixture NH Regular Pre-MountedAET4M3513B2026-04-07
00810126045362ET IV Fixture SA Regular Pre-MountedAET4M3513S2026-04-07
00810126045379ET IV Fixture NH Regular Pre-MountedAET4M3515B2026-04-07
00810126045386ET IV Fixture SA Regular Pre-MountedAET4M3515S2026-04-07
00810126045393ET IV Fixture NH Regular Pre-MountedAET4R4007B2026-04-07
00810126045409ET IV Fixture SA Regular Pre-MountedAET4R4007S2026-04-07
00810126045416ET IV Fixture NH Regular Pre-MountedAET4R4008B2026-04-07
00810126045423ET IV Fixture SA Regular Pre-MountedAET4R4008S2026-04-07
00810126045430ET IV Fixture NH Regular Pre-MountedAET4R4010B2026-04-07
00810126045447ET IV Fixture SA Regular Pre-MountedAET4R4010S2026-04-07
00810126045454ET IV Fixture NH Regular Pre-MountedAET4R4011B2026-04-07
00810126045461ET IV Fixture SA Regular Pre-MountedAET4R4011S2026-04-07
00810126045478ET IV Fixture NH Regular Pre-MountedAET4R4013B2026-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10686864060946MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
10686864060953MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
10194665008444A-decA-DEC, INC.EBW2026-02-19
J021081659501Dongle for foot control S-NW3W & H Dentalwerk Bürmoos GmbHEBW2025-12-18
J021304950001Foot control S-NW3 (Dongle)W & H Dentalwerk Bürmoos GmbHEBW2025-12-18
J021101008011S-8 RW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
J021101008021S-8 OW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
J021101008031S-8 SW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
10686864061141MEDICOM DENTICAREAMD Medicom IncEGS2025-03-18
10686864060915MEDICOM DENTICARE SWIVEL DPA, SOFT CUPAMD Medicom IncEGS2024-09-27
10686864060922MEDICOM DENTICARE SWIVEL DPA, FIRM CUPAMD Medicom IncEGS2024-09-27
10686864060939MEDICOM DENTICARE SWIVEL DPA, TAPERED BRUSHAMD Medicom IncEGS2024-09-27
J021300320021WS-75 LG surgical handpiece, 20:1, MISW & H Dentalwerk Bürmoos GmbHKMW2023-07-11