FDA.reportPublic FDA data

Neodent

Primary DI
07899878065012
Brand
Neodent
Company
JJGC Indústria e Comércio de Materiais Dentários S/A.
Model
103.700
Catalog number
103.700
Device description
SINGLE-USE DRILL 4.0 mm
Published
2026-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZADRILL, DENTAL, INTRAORAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899878065012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899878065012078998780650127899878065012

GMDN Terms#

Term, Definition table
TermDefinition
Fixture/appliance dental drill bit, single-useA shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a motorized handpiece or other power source that provides rotation. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00keep dry

Contacts#

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

Regulatory Flags#

DUNS number
906713888
Device count
1
DM exempt
true
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
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
07899878066927Neodent191.109191.1092026-06-24
07899878066934Neodent191.110191.1102026-06-24
07899878066941Neodent191.111191.1112026-06-24
07899878066958Neodent191.112191.1122026-06-24
07899878066965Neodent191.113191.1132026-06-24
07899878066972Neodent191.114191.1142026-06-24
07899878064985Neodent103.697103.6972026-03-18
07899878064992Neodent103.698103.6982026-03-18
07899878065005Neodent103.699103.6992026-03-18
07899878065029Neodent103.701103.7012026-03-18
07899878065036Neodent103.702103.7022026-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290108819120Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290108819137Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290108819144Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290108819151Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290108819168Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290108819175Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150147EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150178EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150185EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150192EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150208EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150215EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150222EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150239EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150246EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150253EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150260EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150277EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116155623Diamond BurrNORIS MEDICAL LTDDZA2026-08-17
00840456224496JMUJMU DENTAL, INCDZA2026-07-29
00840456224502JMUJMU DENTAL, INCDZA2026-07-29
00840456224519JMUJMU DENTAL, INCDZA2026-07-29
00840456224526JMUJMU DENTAL, INCDZA2026-07-29
00840456224533JMUJMU DENTAL, INCDZA2026-07-29
00840456224540JMUJMU DENTAL, INCDZA2026-07-29
00840456224557JMUJMU DENTAL, INCDZA2026-07-29
00840456224564JMUJMU DENTAL, INCDZA2026-07-29
08806343926302Sinus KitShinhung MST Co., Ltd.DZA2026-07-29
08806343926319Sinus KitShinhung MST Co., Ltd.DZA2026-07-29
08806343926326Sinus KitShinhung MST Co., Ltd.DZA2026-07-29