FDA.reportPublic FDA data

SAFE DENT

Primary DI
00854014003973
Brand
SAFE DENT
Company
BGSS Company Inc.
Model
P5009
Device description
DIGITAL XRAY SENSOR SLEEVE
Published
2024-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NRDUnit, Operative Dental, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854014003980PackageGS124In Commercial Distribution
00854014003973PrimaryGS10
00854014003966Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854014003980008540140039808540140039800854014003980
00854014003973008540140039738540140039730854014003973
00854014003966008540140039668540140039660854014003966

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Regulatory Flags#

DUNS number
828474952
Device count
500
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854014003263SAFE DENTC60112024-05-01
00854014003294SAFE DENTC60122024-05-01
00854014003331SAFE DENTC60132024-05-01
00854014003362SAFE DENTCF60142024-05-01
00810339030001SAFE DENTP50132024-05-01
00810339030032SAFE DENTP5016XL2024-05-01
00810339030063SAFE DENTP50102024-05-01
00810339030094SAFE DENTP50192024-05-15
00810339030124SAFE DENTP50142024-05-01
00810339030162SAFE DENTP5015XL2024-05-01
00810339030193SAFE DENTP50182024-05-01
00810339030483SAFE DENTB2010W2024-05-01
00810339030506SAFE DENTB2011BL2024-05-01
00810339030520SAFE DENTB2012DR2024-05-01
00810339030544SAFE DENTB2013MG2024-05-01
00810339030568SAFE DENTB2014LV2024-05-01
00810339030582SAFE DENTB2015P2024-05-01
00810339030605SAFE DENTB2016Y2024-05-01
00810339030926SAFE DENTBF90167C2024-05-01
00810339030957SAFE DENTBF90166B2024-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454006849COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006856COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006863COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006870COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006887COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006894COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006900COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006917COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454006924COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
06954454016244COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-23
04719965090013INTRAORAL CAMERACHUAN FU MEDICAL INSTRUMENT CO., LTD.NRD2026-10-22
06954454006757COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006764COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006771COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006788COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006795COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006801COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006818COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006825COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454006832COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454013991COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454014004COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454014011COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454014028COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
06954454014035COTISENHuanghua Promisee Dental Co., Ltd.NRD2026-10-22
D832SPD05081PlasdentPLASDENT CORPORATIONNRD2026-07-20
00840456223246JMUJMU DENTAL, INCNRD2026-07-08
00840456223253JMUJMU DENTAL, INCNRD2026-07-08
00840456223260JMUJMU DENTAL, INCNRD2026-07-08
00840456223277JMUJMU DENTAL, INCNRD2026-07-08