FDA.reportPublic FDA data

PLASTIC PIPETTES 1mL - 25 pieces

Primary DI
07640159161585
Brand
PLASTIC PIPETTES 1mL - 25 pieces
Company
Produits dentaires S.A.
Model
11752
Device description
PLASTIC PIPETTES 1mL - 25 pieces One assortment of 5 color-coded pipette For introducing solutions into the root canal or cavities
Published
2022-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EICSyringe, Periodontic, Endodontic, Irrigating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EICSyringe, Periodontic, Endodontic, IrrigatingDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640159161585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640159161585076401591615857640159161585

GMDN Terms#

Term, Definition table
TermDefinition
Dental irrigation/aspiration syringeA hand-held manual dental device (a plunger-type syringe) designed to inject and/or aspirate a volume of solution into the working area in the oral cavity. It typically consists of a small syringe (e.g., 3 ml) and is used for washing and aspirating the pulp cavity and root canal to remove debris. It is hand-operated by the user who exerts a steady pressure on, e.g., thumb rings and/or swivel finger bars, which exerts pressure on the syringe plunger forcing the washing/rinsing fluids through an attached needle (e.g., a blunt or very fine needle) directly at the operative site. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41219212631info@pd-dental.com

Regulatory Flags#

DUNS number
480420090
Device count
1
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
07640159163350Drill-A-Post - N°1225112023-05-24
07640159163367Drill-A-Post - N°2225122023-05-24
07640159163374Drill-A-Post - N°3225132023-05-24
07640159163381Drill-A-Post - N°4225142023-05-24
07640159163398Drill-A-Post - N°1 - Rack of 6 pieces225012023-05-24
07640159163404Drill-A-Post - N°2 - Rack of 6 pieces225022023-05-24
07640159163411Drill-A-Post - N°3 - Rack of 6 pieces225032023-05-24
07640159163428Drill-A-Post - N°4 - Rack of 6 pieces225042023-05-24
07640159161530DS TULSA Generic needle (5)21412DSIN30G52022-06-30
07640159161912TOFFLEMIRE MATRIX BANDS X-THIN N.1415112022-06-29
07640159161929TOFFLEMIRE MATRIX BANDS X-THIN N.2415122022-06-29
07640159161936TOFFLEMIRE MATRIX BANDS X-THIN N.3415132022-06-29
07640159161943TOFFLEMIRE MATRIX BANDS X-THIN N.11415142022-06-29
07640159161950TOFFLEMIRE MATRIX BANDS X-THIN N.13415152022-06-29
07640159161967TOFFLEMIRE MATRIX BANDS X-THIN N.14415162022-06-29
07640159161974TOFFLEMIRE MATRIX BANDS X-THIN N.15415172022-06-29
07640159161981TOFFLEMIRE MATRIX BANDS X-THIN ASSTD415182022-06-29
07640159161998TOFFLEMIRE MATRIX BANDS THIN N°1415212022-06-29
07640159162001TOFFLEMIRE MATRIX BANDS THIN N°2415222022-06-29
07640159162018TOFFLEMIRE MATRIX BANDS THIN N°3415232022-06-29

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