FDA.report

EdgeBurs®

Primary DI
10818365023964
Brand
EdgeBurs®
Company
US ENDODONTICS, LLC
Model
RCSR25
Catalog number
RCSR25
Device description
Polishers Reveal - Cup sterile roll 25 Polishers Reveal - Cup sterile roll 25
Published
2023-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EJLBUR, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00818365023967PrimaryGS10
10818365023964Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00818365023967008183650239678183650239670818365023967
1081836502396410818365023964

GMDN Terms

TermDefinition
Carbide dental bur, single-useA rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(423)283-0047Bobby.bennett@us-endo.com

Regulatory Flags

DUNS number
061317427
Device count
5
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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

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10810047645501EdgeSequel UtopiaES250621SEES250621SE2023-07-28
10810047645518EdgeSequel UtopiaES250625SEES250625SE2023-07-28
10810047645525EdgeSequel UtopiaES250631SEES250631SE2023-07-28
10810047645532EdgeSequel UtopiaES300621SEES300621SE2023-07-28
10810047645549EdgeSequel UtopiaES300625SEES300625SE2023-07-28

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