FDA.report

Brasseler USA

Primary DI
00887919199892
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
003083U0
Device description
161.31.016 LINDEMANN 5P
Published
2022-12-07
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
false

Related Records

Product Codes

CodeName
EKDINSTRUMENT, CUTTING, OPERATIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EKDInstrument, Cutting, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00887919199892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919199892008879191998928879191998920887919199892

GMDN Terms

TermDefinition
Carbide dental bur, reusableA 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 reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
082080136
Device count
1
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
true

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07897990302336MICROCUTTDV DENTAL LTDAEKD2025-02-28
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00885797096340RMORmo, Inc.EKD2024-08-13
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E8963438100SCHWERTA. Schweickhardt GmbH & Co. KGEKD2023-02-22
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07898506841509QuinelatoSchobell Industrial LtdaEKD2022-11-28
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