FDA.report

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

Primary DI
D77811271280
Brand
SCOTT'S SELECT BARBED BROACHES 10/pk 21mm # FINE
Company
SCOTT'S DENTAL SUPPLY L.L.C.
Model
112-7128
Catalog number
112-7128
Device description
BARBED BROACHES (10/pack) Length: 21mm, Size: Fine, Material: Stainless Steel, Color: Blue; 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

Related Records

Contact Domains

Product Codes

CodeName
EKWBROACH, ENDODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EKWBroach, EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D77811271281PrimaryHIBCC0
D77811271280Unit of UseHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

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

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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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
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05060940375243Barbed Broaches, 1, 21ENDOPERFECTION LIMITEDEKW2023-12-12
05060940375250Barbed Broaches, 2, 21ENDOPERFECTION LIMITEDEKW2023-12-12
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05060940375281Barbed Broaches, 5, 21ENDOPERFECTION LIMITEDEKW2023-12-12
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05060940375342Barbed Broaches, 2, 25ENDOPERFECTION LIMITEDEKW2023-12-12
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