FDA.reportPublic FDA data

Avaline Medical NJ LLC

Primary DI
00647679164215
Brand
Avaline Medical NJ LLC
Company
Avaline Medical NJ Limited Liability Company
Model
vk048tb
Catalog number
vk048tb
Device description
Disposable Toothbrushes 48
Published
2022-03-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFWTOOTHBRUSH, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFWToothbrush, ManualDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00647679164215PrimaryGS10
00810077212134Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00647679164215006476791642156476791642150647679164215
00810077212134008100772121348100772121340810077212134

GMDN Terms#

Term, Definition table
TermDefinition
Basic manual toothbrushAn instrument designed to be used by a patient to manually brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device is typically used with toothpaste. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(732)813-7799jstein@avalinemedical.com

Regulatory Flags#

DUNS number
079767953
Device count
48
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810077219904Avaline Medical NJ LLCVKAEP202023-11-04
00810077219911Avaline Medical NJ LLCVKAEP402023-11-04
00810077219928Avaline Medical NJ LLCVKAEP602023-11-04
00810077219935Avaline Medical NJ LLCVKAEP1202023-11-04
00810077219942Avaline Medical NJ LLCVKAEP2402023-11-04
00810077219959Avaline Medical NJ LLCVKAEP4802023-11-04
00810124536794Avaline Medical NJ LLCVK97245VK972452025-12-05
00810124536831Avaline Medical NJ LLCVK97223VK972232025-12-05
00810124536855Avaline Medical NJ LLCVK15236VK152362025-12-05
00810124536886Avaline Medical NJ LLCVK15296VK152962025-12-05
00810124536787Avaline Medical NJ LLCVK97245VK972452025-12-05
00810124536824Avaline Medical NJ LLCVK97223VK972232025-12-05
00810124536848Avaline Medical NJ LLCVK15236VK152362025-12-05
00810124536879Avaline Medical NJ LLCVK15296VK152962025-12-05
00810124536909Avaline Medical NJ LLCVK69576VK695762025-12-05
00810124536923Avaline Medical NJ LLCVK45915VK459152025-12-05
00810124531843Avaline Medical NJ LLC1lb C-Rollx32025-09-03
00810124532116Avaline Medical NJ LLCOEP x252025-09-03
00810124532123Avaline Medical NJ LLCOEP x502025-09-03
00810124532130Avaline Medical NJ LLCOEP x1002025-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00072239332559Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239332566Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239332573Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239332580Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239334812Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239334829Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239334836Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239328002Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239328149Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239330050Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239332313Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239332320Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239332535Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239332542Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239333129Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
10889483565599BALLARD™SUNMED, LLCEFW2026-01-12
00070942007368GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-08-15
00070942007412GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-08-15
10304040192471Henry ScheinHENRY SCHEIN, INC.EFW2025-07-08
20371347019531Advance Dental ProductsThe Atlanta Dental Supply CompanyEFW2025-06-25
00072239331057Dr. Brown'sDr. Brown's CompanyEFW2025-05-23
00072239330418Dr. Brown'sDr. Brown's CompanyEFW2025-05-22
00070942006378GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-05-19
10810063756243KIDS BUDDY ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756250Power Curve ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756267Esprit Ultra Fine ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756274Whisper Tech Ultra-Fine ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756281Power Curve ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756403Power Curve Extra-Soft ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756434KIDS BUDDY ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19