FDA.report

DIAMOND BUR

Primary DI
D7701051933
Brand
DIAMOND BUR
Company
SWEDEN & MARTINA SPA
Model
FG862G/016C
Catalog number
FG862G/016C
Device description
DIAMOND BUR D.016, COARSE GR. LASER MARK
Published
2021-03-26
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
DZADrill, Dental, Intraoral

Product Code Classifications

CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D7701051933PrimaryHIBCC0

GMDN Terms

TermDefinition
Diamond dental bur, reusableA 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 reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
844.862.7846info.us@sweden-martina.com

Regulatory Flags

DUNS number
433815198
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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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D7701609703FINAL CONICAL DRILLFK425-L-SWFK425-L-SW2025-07-24
D7701609733STOP FOR CONICAL DRILL STOP-3842-180-SWSTOP-3842-180-SW2025-07-24
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D7701609763STOP FOR CONICAL DRILL STOP-3842-210-SWSTOP-3842-210-SW2025-07-24
D7701609773STOP FOR CONICAL DRILL STOP-3842-220-SWSTOP-3842-220-SW2025-07-24

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