FDA.reportPublic FDA data

SM7 US ( Complete Set )

Primary DI
00810126043153
Brand
SM7 US ( Complete Set )
Company
HIOSSEN, INC.
Model
Y1500891U
Device description
SM7 complete set - The SM7 is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives 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
00810126043153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810126043153008101260431538101260431530810126043153

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
00810126046888EK MULTI ANGLED ABUTMENTEK17MUA482TH2026-07-31
00810126046895EK MULTI ANGLED ABUTMENTEK17MUA484TH2026-07-31
00810126046901EK MULTI ANGLED ABUTMENTEK17MUA484TH2026-07-31
00810126046918EK MULTI ANGLED ABUTMENTEK30MUA483TH2026-07-31
00810126046925EK MULTI ANGLED ABUTMENTEK30MUA484TH2026-07-31
00810126046932EK MULTI ANGLED ABUTMENTEK30MUA485TH2026-07-31
00810126046949EK MULTI ANGLED ABUTMENTET17MUA482MWH2026-07-31
00810126046956EK MULTI ANGLED ABUTMENTET17MUA482RWH2026-07-31
00810126046963EK MULTI ANGLED ABUTMENTET17MUA483MWH2026-07-31
00810126046970EK MULTI ANGLED ABUTMENTET17MUA483RWH2026-07-31
00810126046987EK MULTI ANGLED ABUTMENTET17MUA484MWH2026-07-31
00810126046994EK MULTI ANGLED ABUTMENTET17MUA484RWH2026-07-31
00810126047007EK MULTI ANGLED ABUTMENTET17MUA485RWH2026-07-31
00810126047014EK MULTI ANGLED ABUTMENTET30MUA483MWH2026-07-31
00810126047021EK MULTI ANGLED ABUTMENTET30MUA483RWH2026-07-31
00810126047038EK MULTI ANGLED ABUTMENTET30MUA484MWH2026-07-31
00810126047045EK MULTI ANGLED ABUTMENTET30MUA484RWH2026-07-31
00810126047052EK MULTI ANGLED ABUTMENTET30MUA485MWH2026-07-31
00810126047069EK MULTI ANGLED ABUTMENTET30MUA485RWH2026-07-31
00810126046871ET III Fixture SA Regular No MountCET3R5018S2026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10686864060946MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
10686864060953MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25