FDA.reportPublic FDA data

SAFE DENT

Primary DI
00810339030261
Brand
SAFE DENT
Company
BGSS Company Inc.
Model
A9019W
Device description
A9019W SURGICAL ASPIRATOR TIPS 1/8" white (inner bag 25)
Published
2024-05-01
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
true

Product Codes#

Code, Name table
CodeName
EHZEvacuator, Oral Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHZEvacuator, Oral CavityDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810339030261PackageGS1100In Commercial Distribution
00810339030254PrimaryGS10
00810339030247Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810339030261008103390302618103390302610810339030261
00810339030254008103390302548103390302540810339030254
00810339030247008103390302478103390302470810339030247

GMDN Terms#

Term, Definition table
TermDefinition
Dental dry field kitA collection of devices and supplies used in orthodontic and restorative dentistry to maintain a dry oral cavity for treatment procedures. It provides the operator with easy access to the field of operation by holding the mouth open, displacing the tongue, and removing saliva during various procedures (e.g., bonding orthodontic brackets, bleaching, applying veneers or pit and fissure sealants, posterior restorations). It typically consists of bite blocks, pad extenders, suction tips of varying sizes, and tubing that connects to a suction system. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
828474952
Device count
25
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
00810339030100SAFE DENTP50192024-05-15
00810339030322SAFE DENTM3010BL2024-05-15
00810339031138SAFE DENTM3011PK2024-05-15
00810339031398SAFE DENTH501392024-05-15
00810339031657SAFE DENTH501382024-05-15
00810339031831SAFE DENTLAB201M-BL2024-05-15
00810339031862SAFE DENTLAB202L-BL2024-05-15
00810339031893SAFE DENTLAB203XL-BL2024-05-15
00854014003034SAFE DENTSTP-7001-A2024-05-15
00854014003065SAFE DENTSTP-7002-B2024-05-15
00854014003096SAFE DENTSTP-7003-C2024-05-15
00854014003126SAFE DENTSTP-7004-D2024-05-15
00854014003157SAFE DENTSTP-7004-E2024-05-15
00854014003188SAFE DENTSTP-7006-F2024-05-15
00854014003645SAFE DENTPT8112W2024-05-15
00854014003683SAFE DENTPT8113BL2024-05-15
00854014003720SAFE DENTPT8114DR2024-05-15
00854014003751SAFE DENTPT8115LV2024-05-15
00854014003812SAFE DENTPT8117MG2024-05-15
00810339030018SAFE DENTP50132024-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126505675Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEHZ2026-03-05
00849296017800WelmedWELMED INC.EHZ2026-02-15
00849296017817WelmedWELMED INC.EHZ2026-02-15
00723896029855Practicon Color Splash™ Saliva Ejectors 100/PackPRACTICON, INC.EHZ2026-01-08
00841336128811Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEHZ2025-11-20
00371347017793Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
00371347017809Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
00371347017816Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
00371347017823Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
00841336105553Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEHZ2025-11-11
00841336105560Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEHZ2025-11-11
00841336105577Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEHZ2025-11-11
00841336108509Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEHZ2025-11-11
00841336108578Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEHZ2025-11-11
00841336109995Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEHZ2025-11-11
00841336110489Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEHZ2025-11-11
00841336111639Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEHZ2025-11-11
00842517104747Karl SchumacherKarl Schumacher Dental, LLCEHZ2025-07-08
00860349001720SWIK Modular MouthpieceSaliva Management Systems, Inc.EHZ2025-06-17
00860349001737SWIK Modular Extension TubingSaliva Management Systems, Inc.EHZ2025-06-17
00842517104129Karl SchumacherKarl Schumacher Dental, LLCEHZ2025-04-23
10371347018445Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-03-04
00814005020006TAQuality Aspirators, Inc.EHZ2025-02-27
0081400502001315P2-90AQuality Aspirators, Inc.EHZ2025-02-27
0081400502003703BATQuality Aspirators, Inc.EHZ2025-02-27
0081400502005115P3AQuality Aspirators, Inc.EHZ2025-02-27
0081400502006803BAQuality Aspirators, Inc.EHZ2025-02-27
0081400502008202BAQuality Aspirators, Inc.EHZ2025-02-27
0081400502009946P3MQuality Aspirators, Inc.EHZ2025-02-27
0081400502010515P2ATQuality Aspirators, Inc.EHZ2025-02-27