FDA.reportPublic FDA data

ZINC OXIDE - 250g

Primary DI
07640159162773
Brand
ZINC OXIDE - 250g
Company
Produits dentaires S.A.
Model
11432
Device description
ZINC OXIDE - 250g (regular setting) Temporary filling and root canal sealing (mixed with Eugenol)
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMBZinc Oxide Eugenol

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMBZinc Oxide EugenolDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640159162773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640159162773076401591627737640159162773

GMDN Terms#

Term, Definition table
TermDefinition
Zinc oxide eugenol dental cementA non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between eugenol and zinc oxide (ZnO). It typically includes some additional fillers/components. After application, this device cannot be reused.

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
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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D161280160AxioIRM XS 38g powder 14ml liquidAxiodent Inc.EMB2024-09-29
D161280170AxioZi-Temp 15g powder 10ml liquidAxiodent Inc.EMB2024-09-29
07898561542205MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561542212Fill Canal Liquid (10 mL) 7898561542212 Maquira MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561542229MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561542236MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561542250MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561546678MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561546685MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
00816526020220MASTER-DENTDENTONICS INCEMB2023-10-31
00816526020237MASTER-DENTDENTONICS INCEMB2023-10-31
05021752001065Alganol Powder 90gASSOCIATED DENTAL PRODUCTS LIMITEDEMB2023-09-11
15060988910045JJ CAREJack Jack LLCEMB2023-07-15
05021752000723Eugenol B.P. Liquid 150mlASSOCIATED DENTAL PRODUCTS LIMITEDEMB2023-07-06
05021752000761Zinc Oxide B.P. Powder 150gASSOCIATED DENTAL PRODUCTS LIMITEDEMB2023-07-06
10852253006240Power Temp Cartridge KitJ. MORITA U.S.A., INCEMB2023-06-07
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D9673001510ZinconolPREVEST DENPRO LIMITEDEMB2023-01-03
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D967300150ZinconolPREVEST DENPRO LIMITEDEMB2022-12-19
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D9673001600ZitempPREVEST DENPRO LIMITEDEMB2022-12-19
H66811475771Keystone IndustriesKeystone IndustriesEMB2022-11-30
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