FDA.reportPublic FDA data

SCOTT'S SELECT GATES DRILLS 6/pk 28mm # 5

Primary DI
D77811253450
Brand
SCOTT'S SELECT GATES DRILLS 6/pk 28mm # 5
Company
SCOTT'S DENTAL SUPPLY L.L.C.
Model
112-5345
Catalog number
112-5345
Device description
GATES DRILLS (6/pack) Length: 28mm, Size: 5, Material: Stainless Steel; For more information: https://www.scottsdental.com/catalog/product/view/id/23532/s/gates-glidden-drills-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
D77811253451PrimaryHIBCC0
D77811253450Unit of UseHIBCC0

GMDN Terms

TermDefinition
Pin/post dental drill bitA shaft of metal, typically with a spiralled portion at the cutting end (a twist drill bit), intended to be attached to a motorized handpiece, or other power source, to create a precise round hole at the appropriate depth in teeth or bone of the oral cavity. This hole or slot is used to secure cast or preformed pins/posts for stabilizing and retaining operative dental appliances. This is a reusable 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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