FDA.reportPublic FDA data

SCOTT'S SELECT BARBED BROACHES 10/pk 21mm # XXXF

Primary DI
D77811271220
Brand
SCOTT'S SELECT BARBED BROACHES 10/pk 21mm # XXXF
Company
SCOTT'S DENTAL SUPPLY L.L.C.
Model
112-7122
Catalog number
112-7122
Device description
BARBED BROACHES (10/pack) Length: 21mm, Size: XXX-Fine, Material: Stainless Steel, Color: White; For more information: https://www.scottsdental.com/catalog/product/view/id/24126/s/barbed-broaches-scott-s-select/
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
EKWBROACH, ENDODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKWBroach, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D77811271221PrimaryHIBCC0
D77811271220Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sonic endodontic broachA non-sterile dental endpiece designed to be attached to a sonic dental handpiece for the application of sonic vibrations to shape and enlarge holes in root canal tissue, particularly dentine, or for extirpating pulp. It is a tapered and serrated/barbed thin rod made of metal. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
137217043
Device count
10
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
true

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
D6620708761020PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761100PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761280PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761360PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761440PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761510PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
D6620708761690PattersonPATTERSON DENTAL SUPPLY, INC.EKW2024-11-11
05060940375236Barbed Broaches, 0, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375243Barbed Broaches, 1, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375250Barbed Broaches, 2, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375267Barbed Broaches, 3, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375274Barbed Broaches, 4, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375281Barbed Broaches, 5, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375298Barbed Broaches, 6, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375304Barbed Broaches, 2-4, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375311Barbed Broaches, 0-6, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375328Barbed Broaches, 0, 25ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375335Barbed Broaches, 1, 25ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375342Barbed Broaches, 2, 25ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375359Barbed Broaches, 3, 25ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375366Barbed Broaches, 4, 25ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375373Barbed Broaches, 5, 25ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375380Barbed Broaches, 6, 25ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375397Barbed Broaches, 2-4, 25ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375403Barbed Broaches, 0-6, 25ENDOPERFECTION LIMITEDEKW2023-12-12
07630049992429Barbed broaches 31mm 025-040, pu: 12 pDiaswiss SAEKW2023-12-01
07630049992443Barbed broaches 31mm 025-060, pu: 12 pDiaswiss SAEKW2023-12-01
D6919053631Premier Barbed BroachesPREMIER DENTAL PRODUCTS COMPANYEKW2023-10-17
D6919053633Premier Barbed BroachesPREMIER DENTAL PRODUCTS COMPANYEKW2023-10-17
D6919053634Premier Barbed BroachesPREMIER DENTAL PRODUCTS COMPANYEKW2023-10-17