FDA.reportPublic FDA data

OROCARE MINI TOOTHBRUSH

Primary DI
05030267098989
Brand
OROCARE MINI TOOTHBRUSH
Company
INTERSURGICAL INCORPORATED
Model
3011000
Device description
OROCARE MINI TOOTHBRUSH
Published
2021-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
05030267098972PackageGS130In Commercial Distribution
05030267098989PackageGS1120In Commercial Distribution
05030267098071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05030267098972050302670989725030267098972
05030267098989050302670989895030267098989
05030267098071050302670980715030267098071

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3154512900support@intersurgicalinc.com

Regulatory Flags#

DUNS number
785952607
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05030267124084ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 0, NEONATE 15M122000051948502025-09-25
05030267124091ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 1, INFANT, 15M122100051948502025-09-25
05030267124107ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 2, PAEDIATRIC, 22F122200051948502025-09-25
05030267123582ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 3, SMALL ADULT, 22F122300051948502025-09-25
05030267124121ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 4, MEDIUM ADULT, 22F122400051948502025-09-25
05030267124077ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 5, LARGE ADULT, 22F122500051948502025-09-25
05030267124138ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 6, EXTRA LARGE ADULT, 22122600051948502025-09-25
05030267165322I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, SMALL ADULT730000151948502025-09-23
05030267165346I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, MEDIUM ADULT730100151948502025-09-23
05030267165360HIGH FLOW NASAL CANNULA WITH ADAPTER, LARGE ADULT730200151948502025-09-23
0503026704595222MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH MONITOR LINE 519185051918502025-04-16
0503026704588422MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH LIMB.1.6M519485051948502025-04-16
05030267001804TRACHEOSTOMY MASK, PAEDIATRIC120600012060002025-04-15
05030267098088PREMATURE, NASAL CANNULA WITH CURVED PRONGS AND TUBE, 2.1M 116000011600002025-04-15
0503026716528522MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVE518301051830102025-04-15
00816472022552Nose Clip with Padding143560002025-04-14
0503026716154622mm Compact breathing system21580192025-04-14
0503026716175122mm Compact breathing system21580122025-04-14
05030267166367I-GEL® PLUS ANAESTHESIA, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG890300089030002025-04-14
05030267166466I-GEL® PLUS ANAESTHESIA, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG.890400089040002025-04-14

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