FDA.reportPublic FDA data

Scan body

Primary DI
06932195394227
Brand
Scan body
Company
Chengdu Besmile Medical Technology Co., Ltd.
Model
PJ-BSM-FH
Published
2026-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06932195394227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06932195394227069321953942276932195394227

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant abutment analog, intraoral-scanning, single-useAn intraoral device intended to be used as a temporary copy of a dental implant abutment for attachment to a final dental implant and/or implant abutment during a scanning procedure to confirm its orientation/position as part of a dental restoration; it may in addition be intended for laboratory scanning. It is typically made of a radiopaque material (e.g., barium sulfate) and may be used in conjunction with an intraoral x-ray sensor. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
554494754
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06932195394999Torque WrenchBSM-BS30-80 (Interval 5) A/B2026-05-29
06932195392322BIORES Dental Implant SystemBSM-ZTG37082026-02-28
06932195392339BIORES Dental Implant SystemBSM-ZTG37102026-02-28
06932195392346BIORES Dental Implant SystemBSM-ZTG37122026-02-28
06932195392353BIORES Dental Implant SystemBSM-ZTG37142026-02-28
06932195392360BIORES Dental Implant SystemBSM-ZTG41082026-02-28
06932195392377BIORES Dental Implant SystemBSM-ZTG41102026-02-28
06932195392384BIORES Dental Implant SystemBSM-ZTG41122026-02-28
06932195392391BIORES Dental Implant SystemBSM-ZTG41142026-02-28
06932195392407BIORES Dental Implant SystemBSM-ZTG43082026-02-28
06932195392414BIORES Dental Implant SystemBSM-ZTG43102026-02-28
06932195392421BIORES Dental Implant SystemBSM-ZTG43122026-02-28
06932195392438BIORES Dental Implant SystemBSM-ZTG43142026-02-28
06932195392445BIORES Dental Implant SystemBSM-ZTG48082026-02-28
06932195392452BIORES Dental Implant SystemBSM-ZTG48102026-02-28
06932195392469BIORES Dental Implant SystemBSM-ZTG48122026-02-28
06932195392476BIORES Dental Implant SystemBSM-ZTG48142026-02-28
06932195392483BIORES Dental Implant SystemBSM-ZTG55082026-02-28
06932195392490BIORES Dental Implant SystemBSM-ZTG55102026-02-28
06932195392506BIORES Dental Implant SystemBSM-ZTG55122026-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800329747899Neobiotech Implant SystemNeobiotech. co., ltdNDP2026-06-02
06932195394999Torque WrenchChengdu Besmile Medical Technology Co., Ltd.NDP2026-05-29
00844868052463T3® ProZimVie US Corp LLCNDP2026-05-28
00844868052470T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052487T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052494T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052500T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052517T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052524T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052531T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052548T3® ShortZimVie US Corp LLCNDP2026-05-28
06947600329107Driver,BLT,Adapter,for handpiece,for tap,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329572Driver,BL/BLT,Adapter,for handpiece,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329909Driver,BL/BLT,NoMount Driver,NC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329923Driver,BL/BLT,NoMount Driver,RC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330691Tap,BLT,Φ3.3mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330707Tap,BLT,Φ4.1mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330714Tap,BLT,Φ4.8mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330721Template Fixation Pin,Φ1.35mmBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330738Driver,NoMount Torque Driver,NC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330745Driver,NoMount Torque Driver,RC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
08059224214320OT EQUATORRHEIN 83 SRLNDP2026-05-27
08059224214344OT EQUATORRHEIN 83 SRLNDP2026-05-27
08435389830160SHORT POSITIONER FOR UNIVERSAL PLUS PLATFORM (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830177UNIVERSAL PLUS PLATFORM POSITIONER (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830443SURGICAL GUIDE TEMPORARY BALL ATTACHMENT; MULTI-IM; Ø4,1 mmBIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
07630031727459NAInstitut Straumann AGNDP2023-09-30
00842092109274Preci 52Preat CorporationNDP2023-07-05
00842092112113Preat Implant ProstheticsPreat CorporationNDP2023-07-03
00842092100486ZimmerPreat CorporationNDP2023-05-08