FDA.reportPublic FDA data

Hysolate

Primary DI
07630392900478
Brand
Hysolate
Company
Dent4You AG
Model
H00841
Device description
Ora-Shield Dental Dam Napkins universal , 50 pcs
Published
2023-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KHRAbsorber, Saliva, Paper

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHRAbsorber, Saliva, PaperDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630392900478PrimaryGS10
17630392900475Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630392900478076303929004787630392900478
1763039290047517630392900475

GMDN Terms#

Term, Definition table
TermDefinition
Saliva absorbentA non-sterile device designed to absorb moisture from the oral cavity during a dental procedure. Also known as a saliva absorber, it can be in a variety of shapes and sizes and is typically made of paper, cotton, or polymeric web, and may have a high-absorbent core. This is a single-use device.

Regulatory Flags#

DUNS number
480152811
Device count
50
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640397422189HYDRIM 112W G4+ Instrument WasherG4-W10001G4-W100012026-02-11
07640397422349HYDRIM 112W G4+ Instrument WasherG4-W10001-LG4-W10001-L2026-02-11
07640397422356HYDRIM 112W G4+ Instrument WasherG4-W10001-RG4-W10001-R2026-02-11
07640397421250HYDRIM C61WD G4 Instrument Washer-DisinfectorC61WD-D01C61WD-D012025-07-22
07640397421267HYDRIM C61WD G4 Instrument Washer-DisinfectorC61WD-D01-LC61WD-D01-L2025-07-22
07640397421274HYDRIM C61WD G4 Instrument Washer-DisinfectorC61WD-D01-RC61WD-D01-R2025-07-22
07640397421281HYDRIM C61WD G4 Instrument Washer-DisinfectorC61WD-D01-LCSC61WD-D01-LCS2025-07-22
07640397421885HYDRIM C61W G4 Instrument WasherC61W-D01C61W-D012025-01-15
07640397421892HYDRIM C61W G4 Instrument WasherC61W-D01-LC61W-D01-L2025-01-15
07640397421908HYDRIM C61W G4 Instrument WasherC61W-D01-RC61W-D01-R2025-01-15
07640397421915HYDRIM L110W Instrument WasherL110W-D01-LL110W-D01-L2025-01-15
07640397421922HYDRIM L110W Instrument WasherL110W-D01-RL110W-D01-R2025-01-15
07640397421939HYDRIM L110W G4 Instrument WasherL110W-D01-G4L110W-D01-G42025-01-15
07640397421946HYDRIM L110W G4 Instrument WasherL110W-D01-G4-LL110W-D01-G4-L2025-01-15
07640397421953HYDRIM L110W G4 Instrument WasherL110W-D01-G4-RL110W-D01-G4-R2025-01-15
07640397421960HYDRIM L110W G4 Instrument WasherL110W-D01SH-G4L110W-D01SH-G42025-01-15
07630243601202ParaCore588658862026-07-07
07630243601219ParaCore588758872026-07-07
07630243601226ParaCore60011391600113912026-07-07
07630243601301ParaCore60011392600113922026-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456201428JMUJMU DENTAL, INCKHR2026-07-08
00840456217696JMUJMU DENTAL, INCKHR2026-06-05
00840456222188JMUJMU DENTAL, INCKHR2026-06-05
00840456222195JMUJMU DENTAL, INCKHR2026-06-05
00840456223000JMUJMU DENTAL, INCKHR2026-06-05
00840456223017JMUJMU DENTAL, INCKHR2026-06-05
00840456201756JMUJMU DENTAL, INCKHR2026-05-27
00840456201763JMUJMU DENTAL, INCKHR2026-05-27
00840456201770JMUJMU DENTAL, INCKHR2026-05-27
00840456201787JMUJMU DENTAL, INCKHR2026-05-27
00840456201794JMUJMU DENTAL, INCKHR2026-05-27
00840456221020JMUJMU DENTAL, INCKHR2026-05-27
10371347011439Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011446Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011453Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011460Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011477Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011484Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011491Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011507Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
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