FDA.reportPublic FDA data

HYJET COLORS DISP A/W SYRINGE TIPS 250/bag ASST

Primary DI
D77824554220
Brand
HYJET COLORS DISP A/W SYRINGE TIPS 250/bag ASST
Company
SCOTT'S DENTAL SUPPLY L.L.C.
Model
245-5422
Catalog number
245-5422
Device description
HYJET COLORS DISP A/W SYRINGE TIPS 250/bag ASST
Published
2021-02-27
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
ECBUNIT, SYRINGE, AIR AND/OR WATER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECBUnit, Syringe, Air And/Or WaterDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D77824554221PrimaryHIBCC0
D77824554220Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental irrigation/aspiration syringeA hand-held manual dental device (a plunger-type syringe) designed to inject and/or aspirate a volume of solution into the working area in the oral cavity. It typically consists of a small syringe (e.g., 3 ml) and is used for washing and aspirating the pulp cavity and root canal to remove debris. It is hand-operated by the user who exerts a steady pressure on, e.g., thumb rings and/or swivel finger bars, which exerts pressure on the syringe plunger forcing the washing/rinsing fluids through an attached needle (e.g., a blunt or very fine needle) directly at the operative site. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)901-3368info@scottsdental.com

Regulatory Flags#

DUNS number
137217043
Device count
250
DM exempt
true
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
D77810701992Scott's Select Cotton Rolls107-0199107-01992024-08-27
D77810702990Scott's Select Non-Woven Sponges 2 x 2 107-0299107-02992024-08-27
D77810704440Scott's Select Non-Woven Sponges 4 x 4107-0444107-04442024-08-27
D77810750500Scott's Select Patient Bibs107-5050107-50502024-08-27
D77810750540Scott's Select Patient Bibs107-5054107-50542024-08-27
D77810750560Scott's Select Patient Bibs107-5056107-50562024-08-27
D77810750580Scott's Select Patient Bibs107-5058107-50582024-08-27
D77819950610Scott's Select ColorFil Flow Single-Shade Prismatic199-5061199-50612024-08-27
D77819950630Scott's Select ColorFil Flow Blocker199-5063199-50632024-08-27
D77819950500Scott's Select ColorFil Single-Shade Prismatic199-5050199-50502024-08-26
D77819950530Scott's Select ColorFil Blocker199-5053199-50532024-08-26
D77819950570Scott's Select ColorFil Single-Shade Prismatic199-5057199-50572024-08-26
D77819950590Scott's Select ColorFil Blocker199-5059199-50592024-08-26
D77835054990Scott's Select Nitrile Gloves350-5499350-54992024-08-22
D77835055000Scott's Select Nitrile Gloves350-5500350-55002024-08-22
D77835055050Scott's Select Nitrile Gloves350-5505350-55052024-08-22
D77835055110Scott's Select Nitrile Gloves350-5511350-55112024-08-22
D77835086300Scott's Select Latex Gloves350-8630350-86302024-08-22
D77835086320Scott's Select Latex Gloves350-3632350-36322024-08-22
D77835086340Scott's Select Latex Gloves350-8634350-86342024-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810208581269NuCareNuCare LLCECB2026-02-03
10810208581266NuCareNuCare LLCECB2026-02-03
20810208581263NuCareNuCare LLCECB2026-02-03
E89627160SCHWERTA. Schweickhardt GmbH & Co. KGECB2025-04-07
03760243009907Classic by RISKONTROLPRODUITS DENTAIRES PIERRE ROLLANECB2025-04-01
10840326423674AstekYoung Innovations, Inc.ECB2025-02-07
00810021436722DCIDCI International, LLCECB2024-12-13
00810021436739DCIDCI International, LLCECB2024-12-13
00810021436746DCIDCI International, LLCECB2024-12-13
00850048528864Amtouch Air/Water Syringe TipsAMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.ECB2024-10-08
00850048528901Amtouch Air/Water Syringe TipsAMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.ECB2024-10-08
00850048528918Amtouch Air/Water Syringe TipsAMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.ECB2024-10-08
00810021433783DCIDCI International, LLCECB2024-08-02
D930205010020JMUJMU DENTAL, INCECB2024-06-27
00810021435947DCIDCI International, LLCECB2024-05-24
20810021435958DCIDCI International, LLCECB2024-05-24
D248B1619B0DurationHAGER WORLDWIDE, INC.ECB2024-05-20
D248B16280Uni-TipHAGER WORLDWIDE, INC.ECB2024-05-20
E8962702090SCHWERTA. Schweickhardt GmbH & Co. KGECB2024-05-16
00810021434216DCIDCI International, LLCECB2024-05-13
00810021435466DCIDCI International, LLCECB2024-05-13
00810021435534DCIDCI International, LLCECB2024-05-13
00810021435541DCIDCI International, LLCECB2024-05-13
00810021435589DCIDCI International, LLCECB2024-05-13
00810021435602DCIDCI International, LLCECB2024-05-13
00810021435633DCIDCI International, LLCECB2024-05-13
00810021435640DCIDCI International, LLCECB2024-05-13
00810021435664DCIDCI International, LLCECB2024-05-13
00810021435671DCIDCI International, LLCECB2024-05-13
00810021435688DCIDCI International, LLCECB2024-05-13