FDA.reportPublic FDA data

I-PROX L (ORANGE) PK OF 6

Primary DI
D2486302141
Brand
I-PROX L (ORANGE) PK OF 6
Company
HAGER WORLDWIDE, INC.
Model
630214
Device description
I-PROX L (ORANGE) PK OF 6
Published
2023-03-23
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
false

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
D2486302141PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal pick/brush, single-useA manual, pointed, oral hygiene device with a soft tip or bristles intended to be used to stimulate and massage the gums to promote good periodontal (gum) condition, and to clean and remove plaque and debris from between the teeth and gingival surfaces. It may also be referred to as an interdental/interproximal brush and is intended for use in the home. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(828)624-3319d.pritchard@hagerworldwide.com

Regulatory Flags#

DUNS number
009277971
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D248938520Uni-Wedge Regular ( Orange)938522026-01-28
D2486300620TS1 Tongue Vacuum Cleaner6300622024-08-20
D2483552470The Prepster (also known as LaminateButler)3552472024-07-15
D2483552520BurButler ( 5 Hole Orange Base w/Lid)3552522024-07-15
D2483552530BurButler ( 10 Hole White Base w/Lid)3552532024-07-15
D2483552540BurButler ( 10 Hole Pink Base w/Lid)3552542024-07-15
D2483552560BurButler ( 10 Hole Blue Base w/Lid)3552562024-07-15
D2483552600BurButler ( 25 Hole Pink Base w/Lid)3552602024-07-15
D2483552620BurButler ( 25 Hole Blue Base w/Lid)3552622024-07-15
D2486054510Mirahold Child6054512024-07-03
D248137720Almore Aluminum Oxide137722024-05-20
D248137730Almore Aluminum Oxide137732024-05-20
D248B1619B0DurationB16212024-05-20
D248B16280Uni-TipB1629C2024-05-20
D2481550180Reso-Pac Hydrophilic Periodontal Dressing1550182016-09-22
D2481550190Reso-Pac Hydrophilic Periodontal Dressing1550192016-09-22
D2483553190Plast Frame3553192024-04-16
D248222300SafeDispense - Silver222302024-04-12
D248222310Mini SafeDispense222312024-04-12
D248222360SafeDispense - White222362024-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817169029892Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEFW2026-03-05
00810126504371Dream by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEFW2025-12-16
10884392008427Safety 1stDOREL JUVENILE GROUP, INC.EFW2025-12-15
10889483563403BALLARD™SUNMED, LLCEFW2025-12-01
10070942007365GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-08-15
10070942007419GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-08-15
20070942008093GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-08-15
10855424008487Freshen-UpMKJ Brands Limited Liability CompanyEFW2025-08-01
00304040192474Henry ScheinHENRY SCHEIN, INC.EFW2025-07-08
00194346458844EquateWAL-MART STORES, INC.EFW2025-07-07
06935883900014UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
06935883900021UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
06935883900038UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
06935883900045UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
06935883900052UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
06935883900069UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
06935883900076UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
06935883900083UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
06935883900090UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
06935883900106UbbiHuizhou LVB Maternal & Infant Supplies Co., Ltd.EFW2025-06-16
00810180842044DynaCare Kids, Kids Toothbrushes, Assorted Colors, Soft Nylon Bristles Dynarex CorporationEFW2025-06-02
00072239331057Dr. Brown'sDr. Brown's CompanyEFW2025-05-23
00072239330418Dr. Brown'sDr. Brown's CompanyEFW2025-05-22
20070942006372GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-05-19
20070942008109GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-05-19
20070942008116GUM Technique Deep CleanSUNSTAR AMERICAS, INC.EFW2025-05-19
20810063756240KIDS BUDDY ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
20810063756257Power Curve ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
20810063756264Esprit Ultra Fine ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
20810063756271Whisper Tech Ultra-Fine ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19