FDA.report

Offset Osteotome

Primary DI
D785OSTOS340
Brand
Offset Osteotome
Company
OCO BIOMEDICAL INC
Model
3.4mm Offset Osteotome
Catalog number
OST-OS 3.4
Device description
3.4mm Offset Osteotome 3.4mm Diameter
Published
2016-04-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DZNInstruments, Dental Hand

Product Code Classifications

CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D785OSTOS340PrimaryHIBCC0

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
094146123
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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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