FDA.reportPublic FDA data

ORABLOC

Primary DI
08053610771862
Brand
ORABLOC
Company
TECNOFAR SPA
Model
Orabloc Needle twenty7S
Device description
Orabloc Needle twenty7S
Published
2023-06-22
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
DZMNeedle, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZMNeedle, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08053610771862PrimaryGS10
08053610771916Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08053610771862080536107718628053610771862
08053610771916080536107719168053610771916

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 Gauge27Gauge

Contacts#

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

Regulatory Flags#

DUNS number
428682363
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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
08053610771879ORABLOCOrabloc Needle twenty7L2023-06-22
08053610771886ORABLOCOrabloc Needle twenty5L2023-06-22
08053610771893ORABLOCOrabloc Needle thirthyS2023-06-22
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