FDA.report

Offset Osteotome Kit

Primary DI
D785OSTOSKIT0
Brand
Offset Osteotome Kit
Company
OCO BIOMEDICAL INC
Model
Offset Osteotome Kit (4)
Catalog number
OST-OS kit
Device description
Offset Osteotome Kit (4) All 4 with case 1.8mm Offset Osteotome 2.65mm Offset Osteotome 3.4mm Offset Osteotome 4.4mm Offset Osteotome
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
D785OSTOSKIT0PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental osteotome setA collection of dental surgical osteotomes used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. This device typically contains osteotomes of varying sizes and shapes and a surgical mallet or hammer. These are used for ridge expanding, bone condensing and sinus floor elevation procedures. 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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