FDA.report

Parkell®

Primary DI
10810000528018
Brand
Parkell®
Company
PARKELL, INC.
Model
SDS-862-014M
Catalog number
SDS-862-014M
Device description
862-014M Sterile FG Diamond Burs, Flame, Medium Grit
Published
2019-07-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DZPInstrument, Diamond, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810000528018PrimaryGS10
00810000528011Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081000052801810810000528018
00810000528011008100005280118100005280110810000528011

GMDN Terms

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

Device Sizes

TypeValueUnit
Length8Millimeter
Outer Diameter1.4Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
6312491134customerservice@parkell.com

Regulatory Flags

DUNS number
009900424
Device count
10
DM exempt
false
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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