FDA.reportPublic FDA data

KOMET Intraoral dental drill for root posts

Primary DI
E226014324A21
Brand
KOMET Intraoral dental drill for root posts
Company
Gebr. Brasseler GmbH & Co. KG
Model
152BKS.204. 3.A2
Catalog number
152BKS.204. 3
Published
2023-01-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DZADRILL, DENTAL, INTRAORAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E226014324A21PrimaryHIBCC0
E226014324A28Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
317409001
Device count
5
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E226018235A31KOMET ReamerG180.204.130.A3G180.204.1302023-02-01
14053613001998KOMET Surgical BurNC0612.004..M0NC0612.004.2023-01-31
14053613002322KOMET Surgical BurNS0101.012..M0NS0101.012.2023-01-31
14053613053232KOMET Surgical BurNS4101.009..M0NS4101.009.2023-02-01
14053613054222KOMET Surgical BurNS4001.027..M0NS4001.027.2023-02-01
14053613167298KOMET Surgical BurNS4002.027..M0NS4002.027.2023-02-01
14053613174227KOMET Surgical Saw BladeKMS2595.M62..M2KMS2595.M62.2023-02-01
14053613201060KOMET Surgical Saw BladeKM71125.C00..M0KM71125.C00.2023-09-29
14053613205525KOMET Surgical BurNC0186.016..M0NC0186.016.2023-02-01
14053613266892KOMET Surgical BurND1905.009..M0ND1905.009.2023-02-01
14053613266915KOMET Surgical BurND1903.004..M0ND1903.004.2023-01-31
14053613267578KOMET Surgical BurNS0101.012..K2NS0101.012.2023-01-31
14053613268599KOMET Surgical BurNS4101.009..K2NS4101.009.2023-02-01
14053613268612KOMET Surgical BurNS3601.027..K2NS3601.027.2023-02-01
14053613268650KOMET Surgical BurNS4002.027..K2NS4002.027.2023-02-01
14053613272435KOMET Surgical BurND1903.004..K2ND1903.004.2023-01-31
14053613273418KOMET Surgical BurND2001.004..K2ND2001.004.2023-01-31
14053613274491KOMET Surgical Saw BladeKM8672. AC..K2KM8672. AC.2023-02-01
14053613274514KOMET Surgical Saw BladeKM8673. AC..K2KM8673. AC.2023-02-01
14053613275160KOMET Surgical Saw BladeKM005.000..K2KM005.000.2023-02-01

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Primary DI, Brand, Company table
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