FDA.report

SST Named

Primary DI
00814005023830
Brand
SST Named
Company
Quality Aspirators, Inc.
Model
SST Named
Catalog number
314-10000
Device description
SST Named
Published
2025-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EHZEvacuator, oral cavity

Product Code Classifications

CodeDeviceSpecialtyClass
EHZEvacuator, Oral CavityDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00814005023830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00814005023830008140050238308140050238300814005023830

GMDN Terms

TermDefinition
Dental suction system cannula, reusableA semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is made of metal or plastic materials that can be sterilized. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
121431159
Device count
1
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
false
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 DIBrandModelCatalogPublished
00814005020006TATA300-100002025-02-27
0081400502001315P2-90A15P2-90A300-100012025-02-27
0081400502003703BAT03BAT300-100032025-02-27
0081400502005115P3A15P3A300-100062025-02-27
0081400502006803BA03BA300-100072025-02-27
0081400502008202BA02BA300-100092025-02-27
0081400502009946P3M46P3M300-100102025-02-27
0081400502010515P2AT15P2AT300-100112025-02-27
0081400502013615P2A15P2A300-100142025-02-27
00814005020143FR3FR3300-100152025-02-27
00814005020174FR15P2FR15P2300-100182025-02-27
00814005020181FR2FR2300-100192025-02-27
00814005020198FR4FR4300-100202025-02-27
0081400502020446P3AT46P3AT300-100212025-02-27
0081400502021115P2-1/415P2-1/4300-100222025-02-27
0081400502022815P3-1/415P3-1/4300-100232025-02-27
0081400502023556P256P2300-100242025-02-27
0081400502024256P356P3300-100252025-02-27
0081400502026615P3HO15P3HO300-100272025-02-27
0081400502027315P3AT15P3AT300-100292025-02-27

Other Devices Sharing Product Codes

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