FDA.reportPublic FDA data

ORABLOC

Primary DI
08053610771893
Brand
ORABLOC
Company
TECNOFAR SPA
Model
Orabloc Needle thirthyS
Device description
Orabloc Needle thirthyS
Published
2023-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZMNeedle, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZMNeedle, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08053610771848PrimaryGS10
08053610772203PrimaryGS10
08053610772791PrimaryGS10
08053610771893Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08053610771848080536107718488053610771848
08053610772203080536107722038053610772203
08053610772791080536107727918053610772791
08053610771893080536107718938053610771893

GMDN Terms#

Term, Definition table
TermDefinition
Dental syringe needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument with an integral hub, typically intended to be attached to a dental cartridge syringe for the injection of local anaesthetics. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge30Gauge

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+39 0342684115quality@tecnofar.it

Regulatory Flags#

DUNS number
428682363
Device count
100
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08053610772777SIRIOSIRIO 27Gx35 FA112024-05-27
08053610772784SIRIOSIRIO 27Gx38 FA112024-05-27
08053610772791SIRIOSIRIO 30Gx25 FA112024-05-27
08053610772814SIRIOSIRIO 27Gx38 FA112024-05-27
08053610772203SUPPRA JECT SUPPRA JECT 30Gx252023-10-17
08053610772210SUPPRA JECT SUPPRA JECT 30Gx102023-10-17
08053610772227SUPPRA JECT SUPPRA JECT 27Gx252023-10-17
08053610772234SUPPRA JECT SUPPRA JECT 27Gx352023-10-17
08053610771619FAIRFAX DENTALFairfax Dental 27Gx82023-07-24
08053610771626FAIRFAX DENTALFairfax Dental 27Gx322023-07-24
08053610771633FAIRFAX DENTALFairfax Dental 30Gx212023-07-24
08053610772098FAIRFAX DENTALFairfax Dental 27Gx82023-07-24
08053610772104FAIRFAX DENTALFairfax Dental 27Gx322023-07-24
08053610772111FAIRFAX DENTALFairfax Dental 30Gx212023-07-24
08053610771848ORABLOCOrabloc Needle thirthyS2023-06-22
08053610771855ORABLOCOrabloc Needle thirthyES2023-06-22
08053610771862ORABLOCOrabloc Needle twenty7S2023-06-22
08053610771879ORABLOCOrabloc Needle twenty7L2023-06-22
08053610771886ORABLOCOrabloc Needle twenty5L2023-06-22
08053610771909ORABLOCOrabloc Needle thirthyES2023-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D1250802Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D1250812Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D1250822Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D125YS10012Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D125YS10022Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D125YS10072Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D125YS10122Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D832BLT1011PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT2001PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT2011PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT3001PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT3011PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT3021PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4181PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4201PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4211PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4221PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4231PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4251PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT4271PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT5221PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT522B1PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT5231PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT523B1PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT5251PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT525B1PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT6301PlasdentPLASDENT CORPORATIONDZM2026-05-01
D832BLT630M1PlasdentPLASDENT CORPORATIONDZM2026-05-01
20192253037422MonojectCardinal Health 200, LLCDZM2026-04-02
20192253037446MonojectCardinal Health 200, LLCDZM2026-04-02