FDA.reportPublic FDA data

Neodent

Primary DI
07899878001171
Brand
Neodent
Company
JJGC Indústria e Comércio de Materiais Dentários S/A.
Model
110.163
Catalog number
110.163
Device description
CONVEX OSTEOTOME
Published
2022-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMMCHISEL, OSTEOTOME, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMMChisel, Osteotome, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899878001171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899878001171078998780011717899878001171

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter3.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)412-8883customerservice.us@instradent.com

Regulatory Flags#

DUNS number
906713888
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899878068181Neodent118.413118.4132026-09-25
07899878068198Neodent118.414118.4142026-09-25
07899878068211Neodent138.196138.1962026-09-25
07899878068228Neodent138.197138.1972026-09-25
07899878068235Neodent116.309116.3092026-09-25
07899878068242Neodent116.308116.3082026-09-25
07899878068259Neodent118.415118.4152026-09-25
07899878068266Neodent104.075104.0752026-09-25
07899878068273Neodent104.078104.0782026-09-25
07899878068280Neodent104.076104.0762026-09-25
07899878068297Neodent104.077104.0772026-09-25
07899878066989Neodent106.281106.2812026-07-03
07899878066996Neodent106.282106.2822026-07-03
07899878067009Neodent106.283106.2832026-07-03
07899878067016Neodent106.284106.2842026-07-03
07899878067023Neodent106.285106.2852026-07-03
07899878067030Neodent106.286106.2862026-07-03
07899878067047Neodent106.287106.2872026-07-03
07899878067054Neodent106.288106.2882026-07-03
07899878067061Neodent106.289106.2892026-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G879OSTCVC220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVC270DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVC320DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVC370DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVC420DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVS220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVS270DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVS320DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVS370DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCVS420DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXC220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXC270DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXC320DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXC370DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXC420DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXS220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXS270DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXS320DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXS370DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
G879OSTCXS420DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMM2026-08-18
04099797012989SCREW-LINE Osteotomy setALTATEC GmbHEMM2026-08-17
04099797012996SCREW-LINE Osteotomy setALTATEC GmbHEMM2026-08-17
04099797013016SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17
04099797013047SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17
04099797013078SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17
04099797013108SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17
04099797013139SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17
04099797013153SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17
04099797013184SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17
04099797013214SCREW-LINE OsteotomeALTATEC GmbHEMM2026-08-17