FDA.reportPublic FDA data

Brasseler USA

Primary DI
08404535019018
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5031821U0
Catalog number
5031821U0
Device description
LYON PERIO PRE-CLINIC CASSETTE
Published
2026-06-26
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
false

Product Codes#

Code, Name table
CodeName
EMSCURETTE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMSCurette, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08404535019018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08404535019018084045350190188404535019018

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal curetteA hand-held dental instrument with a sharp, hollow-ground blade, usually rounded and semicircular in cross-section, used with a pulling action to remove calculus of periodontal pockets and smooth root surfaces; it is not a gingival retraction cord packing tool. It is typically a double-ended instrument with a handle positioned centrally and is made of metal. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
082080136
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887919581727DENTFLEX FIBER POST5013918L05013918L02026-09-25
00887919581741DENTFLEX FIBER POST5013919L05013919L02026-09-25
00887919581765DENTFLEX FIBER POST5013920L05013920L02026-09-25
08404535030334Brasseler USA5032038U05032038U02026-09-25
08404535030365Brasseler USA5032039U05032039U02026-09-25
08404535030396Brasseler USA5032040U05032040U02026-09-25
08404535030426Brasseler USA5032041U05032041U02026-09-25
08404535030433Brasseler USA5032042U05032042U02026-09-25
08404535030464Brasseler USA5032043U05032043U02026-09-25
08404535030488Brasseler USA5032044U05032044U02026-09-25
08404535030518Brasseler USA5032045U05032045U02026-09-25
08404535030549Brasseler USA5032046U05032046U02026-09-25
08404535030570Brasseler USA5032047U05032047U02026-09-25
08404535030600Brasseler USA5032048U05032048U02026-09-25
08404535030631Brasseler USA5032049U05032049U02026-09-25
08404535030662Brasseler USA5032050U05032050U02026-09-25
00887919673866Brasseler USA5022561U05022561U02023-01-25
00887919676201Brasseler USA5022789U05022789U02023-01-25
00887919749981Brasseler USA5025306U05025306U02023-01-25
00887919752301Brasseler USA5025362U05025362U02023-01-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G879102188H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102198H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102207H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102208H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102209H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102210H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102214H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102215H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879102216H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC11120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC13140DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC15160DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC17180DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC560DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC780DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GC9100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM11120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM13140DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM560DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM780DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCM9100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCTIT11120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCTIT120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCTIT13140DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCTIT340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14
G879GCTIT560DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMS2026-08-14