FDA.report

CULLUM SINUS FLOOR ELEV KIT

Primary DI
D928CSFE0
Brand
CULLUM SINUS FLOOR ELEV KIT
Company
W.H. Holden, Inc.
Model
CSFE
Published
2024-01-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GFIOSTEOTOME, MANUAL

Product Code Classifications

CodeDeviceSpecialtyClass
GFIOsteotome, ManualGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D928CSFE0PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental osteotomeA hand-held, dental, surgical instrument used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. It is hand-held by the dentist who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The device will have a straight or bayonet-shaped handle leading to a round or concave tip at the distal end, which may be marked with graduations to indicate depth differences. It is used for ridge expanding, bone condensing and sinus floor elevation procedures. This device will be made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
183854322
Device count
1
DM exempt
false
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

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D928400102HF0PERIO KNIFE GOLDMAN FOX 11 HF HANDLE40-0102HF2026-01-14
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D928105106HDHFDLC0CURETTE MOLT 2/4HD, HF D/E DLC10-5106HDHF-DLC2026-01-06
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D928105402HF0PERIOSTEAL ELEVATOR LANGER, MIRROR FINISH, HF D/E10-5402HF2026-01-06
D928105410CH0PERIOSTEAL ELEVATOR HOWARD #9H CH D/E10-5410CH2026-01-06
D928105488CHDLC0PERIOSTEAL ELEVATOR WOODSON SPEAR AND PERIO KNIFE, CH D/E DLC10-5488CHDLC2026-01-06
D928105489RK0PERIOSTEAL ELEVATOR, MODIFIED BUSER, ROUND KNURLED HANDLE, D/E10-5489RK2026-01-06
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