FDA.reportPublic FDA data

DryDent

Primary DI
17310234160693
Brand
DryDent
Company
Directa AB
Model
Sublingual S
Catalog number
416069
Published
2022-12-06
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
17310234160693PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1731023416069317310234160693

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
353954381
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17310235115869Directa Cheek Retractor Red Adult5115862022-12-07
17310235115876Directa Cheek Retractor Red Child5115872022-12-07
17310235115906Directa Cheek Retractor Ivory Adult5115902022-12-07
17310235115913Directa Cheek Retractor Ivory Child 5115912022-12-07
17310236901089ProphyCare HAp6901082025-09-01
17310231029993ProphyCare HAp6901082025-09-01
17310234160679DryDent Sublingual X-Small4160672022-12-06
17310230021967PrepSure1.0 mm2025-05-27
17310230021974PrepSure1.5 mm2025-05-27
17310230021981PrepSure2.0 mm2025-05-27
17310230924039PrepSure92403924032025-05-27
17310230004045TrollByteLynx Blue #115412450012022-12-06
17310230004052TrollByteLynx Blue #215413150022022-12-06
17310230004069TrollByteLynx Yellow #115434050012022-12-05
17310230004076TrollByteLynx Yellow #215434150022022-12-05
17310236901195ProphyCareMix Single Dose6901192022-12-07
17310230001228TrollBagPSP #1131904032022-12-06
17310230004922TrollByteEzSoft #1155005102022-12-06
17310230004946TrollByteEzSoft #2155005202022-12-06
17310230006674TrollByteEzSoft #2 (Wave)155006202022-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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