FDA.report

SCOTT'S SELECT PEESO REAMERS 6/pk 28mm # 4

Primary DI
D77811263440
Brand
SCOTT'S SELECT PEESO REAMERS 6/pk 28mm # 4
Company
SCOTT'S DENTAL SUPPLY L.L.C.
Model
112-6344
Catalog number
112-6344
Device description
PEESO REAMERS (6/pack) Length: 28mm, Size: 4, Material: Stainless Steel; For more information: https://www.scottsdental.com/catalog/product/view/id/23609/s/peeso-reamers-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
DZADRILL, DENTAL, INTRAORAL

Product Code Classifications

CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D77811263441PrimaryHIBCC0
D77811263440Unit of UseHIBCC0

GMDN Terms

TermDefinition
Rotary/reciprocating endodontic file/rasp, single-useA dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as a rotary or engine file, or reamer. 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
6
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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