FDA.report

Brasseler USA

Primary DI
00818365020232
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5028586G0
Device description
EDGE BIOCERAMIC TERMALFLOW 1.5G
Published
2022-12-01
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
KIFRESIN, ROOT CANAL FILLING

Product Code Classifications

CodeDeviceSpecialtyClass
KIFResin, Root Canal FillingDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00818365020232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00818365020232008183650202328183650202320818365020232

GMDN Terms

TermDefinition
Calcium hydroxide dental cementA non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., pulp capping, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between calcium hydroxide and salicylic acid (or related esters such as butan-1,3-diol disalicylate). It typically includes some additional fillers/components. After application, this device cannot be reused.

Sterilization Methods

Method

Regulatory Flags

DUNS number
082080136
Device count
1
DM exempt
false
Premarket exempt
false
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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