FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919784999
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5026090U0
Device description
TIC13/14 IMPLANTPRO 13/14 CUR
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EKECURETTE, OPERATIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKECurette, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887919784999PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919784999008879197849998879197849990887919784999

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
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887919170488Brasseler USA Sterile Carbide000388SP000388SP2026-05-27
00887919227335Brasseler USA Sterile Diamond004878SP004878SP2026-05-27
00887919317036Brasseler USA Sterile Diamond017274SP017274SP2026-05-27
08404535029468Brasseler USA Sterile Diamond004164SP004164SP2026-05-27
08404535029499Brasseler USA Sterile Diamond004325SP004325SP2026-05-27
08404535029529Brasseler USA Sterile Diamond004529SP004529SP2026-05-27
08404535029550Brasseler USA Sterile Diamond004801SP004801SP2026-05-27
08404535029581Brasseler USA Sterile Diamond004818SP004818SP2026-05-27
08404535029611Brasseler USA Sterile Diamond004820SP004820SP2026-05-27
08404535029642Brasseler USA Sterile Diamond004868SP004868SP2026-05-27
08404535029673Brasseler USA Sterile Diamond004959SP004959SP2026-05-27
08404535029703Brasseler USA Sterile Diamond005034SP005034SP2026-05-27
08404535029734Brasseler USA Sterile Diamond005043SP005043SP2026-05-27
08404535029765Brasseler USA Sterile Diamond005046SP005046SP2026-05-27
08404535029796Brasseler USA Sterile Diamond005056SP005056SP2026-05-27
08404535029826Brasseler USA Sterile Diamond005255SP005255SP2026-05-27
08404535029857Brasseler USA Sterile Diamond005256SP005256SP2026-05-27
08404535029888Brasseler USA Sterile Diamond005372SP005372SP2026-05-27
08404535029918Brasseler USA Sterile Diamond012223SP012223SP2026-05-27
08404535029949Brasseler USA Sterile Diamond013287SP013287SP2026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D928105106HDHFDLC0CURETTE MOLT 2/4HD, HF D/E DLCW.H. Holden, Inc.EKE2026-01-06
D928105109JHF59DLC0CURETTE BONE #9J HF D/E SHORT HANDLE DLCW.H. Holden, Inc.EKE2026-01-06
D928105113CH0SINUS CURETTE D/E GOLEC CHW.H. Holden, Inc.EKE2025-02-06
D928105159CH0SINUS CURETTE K-N OBTUSE SMITH CH D/EW.H. Holden, Inc.EKE2024-12-18
D928105102HDFE0CURETTE MOLT #2HD EH-SM S/E **SPECIAL FLAT TIP**W.H. Holden, Inc.EKE2024-12-17
D928105104HO0CURETTE MOLT #4HD H/O HANDLEW.H. Holden, Inc.EKE2024-12-17
D92810510524RCH0CURETTE MOLT 2CH / 4HD, RIGHT, CH D/EW.H. Holden, Inc.EKE2024-12-17
D9281051066HFDLC0MOLT 4 DULL LEFT / RIGHT CURETTE, DLC, ACCORDING TO DR. CHANW.H. Holden, Inc.EKE2024-12-17
D928105109SHD0BONE CURETTE #9, STRAIGHT, 3.15mm /3.75MM, D/E SERRATED HDW.H. Holden, Inc.EKE2024-12-17
D92810511501HD0SINUS CURETTE B-2 MINI - CUSTOM INSTRUMENT HDW.H. Holden, Inc.EKE2024-12-17
D92810510524LCH0CURETTE MOLT 2CH / 4HD, LEFT, CH D/EW.H. Holden, Inc.EKE2024-12-03
D92810519916CH0CURETTE MOLT #4CH CH SPECIAL D/EW.H. Holden, Inc.EKE2024-12-03
D92810519916HF0CURETTE MOLT #4HD HF HANDLE SPECIAL D/EW.H. Holden, Inc.EKE2024-12-03
D928837102Z0BONE AUGMENTATION KIT ACC TO DR DANIEL CULLUMW.H. Holden, Inc.EKE2024-01-19
D928837151H0BONE TUNNELING KITW.H. Holden, Inc.EKE2024-01-19
D928837160H0LATERAL WINDOW SINUS CURETTE KIT ACC. TO DR. BART SILVERMANW.H. Holden, Inc.EKE2024-01-19
D9282007030ARNETT BONE CURETTEW.H. Holden, Inc.EKE2023-12-20
D9282007070ANTERIOR SINUS WALL CURETTEW.H. Holden, Inc.EKE2023-12-20
D928105102CH0CURETTE MOLT #2CH CH S/EW.H. Holden, Inc.EKE2023-10-10
D928105102CHE0CURETTE MOLT #2CH EH-SM S/EW.H. Holden, Inc.EKE2023-10-10
D928105102CHFE0CURETTE MOLT #2CH EH-SM S/E **SPECIAL FLAT TIP**W.H. Holden, Inc.EKE2023-10-10
D928105102CHHF0CURETTE MOLT #2CH HF S/EW.H. Holden, Inc.EKE2023-10-10
D928105102HD0CURETTE MOLT #2HD HD S/EW.H. Holden, Inc.EKE2023-10-10
D928105102HDE0CURETTE MOLT #2HD EH-SM S/EW.H. Holden, Inc.EKE2023-10-10
D928105102HDF0CURETTE MOLT #2HD HD S/E FLAT TIPW.H. Holden, Inc.EKE2023-10-10
D928105102HDH0CURETTE MOLT #2HD HF S/EW.H. Holden, Inc.EKE2023-10-10
D928105104CH0CURETTE MOLT #4CH CH S/EW.H. Holden, Inc.EKE2023-10-10
D928105104CHE0CURETTE MOLT #4CH EH-SM S/EW.H. Holden, Inc.EKE2023-10-10
D928105104CHLAKE0CURETTE MOLT #4CH CH SPECIAL D/EW.H. Holden, Inc.EKE2023-10-10
D928105104HD0CURETTE MOLT #4HD HD S/EW.H. Holden, Inc.EKE2023-10-10