FDA.report

Cybercut

Primary DI
D950LS00311
Brand
Cybercut
Company
LARES RESEARCH
Model
Single use diamond 847KR-016C
Catalog number
LS0031
Device description
SINGLE USE DIAMOND 847KR-016C - ROLL 25
Published
2025-04-30
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

Product Codes

CodeName
DZPInstrument, Diamond, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D950LS00311PrimaryHIBCC0

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.

Sterilization Methods

Method

Contacts

PhoneEmail
8883338440bholderbein@laresdental.com

Regulatory Flags

DUNS number
009127838
Device count
1
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D950135110SmoothdriveMotor Control System with Fluoresce HD135112025-09-01
D950135030Smoothdrive1:1 Contra Angle135032025-08-25
D950116461PastelProphy angle116462025-05-02
D950116471PastelProphy paste116472025-05-02
D950116481PastelProphy paste116482025-05-02
D950LC00011CybercutFG Carbide 1/2LC00012025-05-02
D950LC00021CybercutFG CARBIDE 1/4LC00022025-05-02
D950LC00031CybercutFG CARBIDE 1557LC00032025-05-02
D950LC00041CybercutFG CARBIDE 1558LC00042025-05-02
D950LC00051CybercutFG CARBIDE 169LC00052025-05-02
D950LC00061CybercutFG CARBIDE 169LC00062025-05-02
D950LC00071CybercutFG CARBIDE 2LC00072025-05-02
D950LC00081CybercutFG CARBIDE 245LC00082025-05-02
D950LC00091CybercutFG CARBIDE 245LC00092025-05-02
D950LC00101CybercutFG CARBIDE 33 1/2LC00102025-05-02
D950LC00111CybercutFG CARBIDE 330LC00112025-05-02
D950LC00121CybercutFG CARBIDE 330 LONGLC00122025-05-02
D950LC00131CybercutFG CARBIDE 330 SHORT SHANKLC00132025-05-02
D950LC00141CybercutFG CARBIDE 35LC00142025-05-02
D950LC00151CybercutFG CARBIDE 37LC00152025-05-02

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