FDA.report

Brasseler USA

Primary DI
00887919784906
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5026087U0
Device description
TI4R/4L IMPLANTPRO 4R/4L CUR 1P
Published
2022-12-08
Public version status
Update
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
EKECURETTE, OPERATIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EKECurette, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00887919784906PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919784906008879197849068879197849060887919784906

GMDN Terms

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
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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D928105104HO0CURETTE MOLT #4HD H/O HANDLEW.H. Holden, Inc.EKE2024-12-17
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D92810510524LCH0CURETTE MOLT 2CH / 4HD, LEFT, CH D/EW.H. Holden, Inc.EKE2024-12-03
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D9282007030ARNETT BONE CURETTEW.H. Holden, Inc.EKE2023-12-20
D9282007070ANTERIOR SINUS WALL CURETTEW.H. Holden, Inc.EKE2023-12-20
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