FDA.reportPublic FDA data

CLEANING CURETTE NiTi N.2 Blue

Primary DI
07640159160250
Brand
CLEANING CURETTE NiTi N.2 Blue
Company
Produits dentaires S.A.
Model
20243
Device description
CLEANING CURETTE NiTi N.2 BlueDiam 1.30
Published
2022-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKICarrier, Amalgam, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKICarrier, Amalgam, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640159160250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640159160250076401591602507640159160250

GMDN Terms#

Term, Definition table
TermDefinition
Dental amalgam carrierA hand-held dental instrument specially designed to collect, transport and deposit amalgam in its plastic state into prepared cavities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
480420090
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640159162711ROSEN ROOT-CANAL CEMENT102452022-06-15
07640159162728Eugenol - 15ml114202022-06-15
07640159162735Eugenol - 30 ml114212022-06-15
07640159162742Eugenol - 100 ml114222022-06-15
07640159162759ZINC OXIDE - 500g114302022-06-15
07640159162766ZINC OXIDE - 100g114312022-06-15
07640159162773ZINC OXIDE - 250g114322022-06-15
07640159162780ZINC OXIDE - 1'000g114332022-06-15
07640159162704EssenSeal10246EssenSeal2022-06-13
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
07640159160076HOOKED NEEDLE N. 1 RED202642022-06-21
07640159160083HOOKED NEEDLE N. 2 BLUE202652022-06-21
07640159160359CLASSIC NEEDLE N. 0 YELLOW202202022-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB8180TBS BASICSACME ENTERPRISE.EKI2026-05-18
G149TBSB8190TBS BASICSACME ENTERPRISE.EKI2026-05-18
00371347023428Advance Dental ProductsThe Atlanta Dental Supply CompanyEKI2026-04-14
00348783008753Premier Amalgam CarrierPREMIER DENTAL PRODUCTS COMPANYEKI2026-03-18
00348783008760Premier Amalgam CarrierPREMIER DENTAL PRODUCTS COMPANYEKI2026-03-17
08800075627698OSUNG MNDOSUNG MND Co., Ltd.EKI2025-11-03
07898078650134SPEED GUNAngelus Industria de Produtos Odontologicos S AEKI2025-03-20
07898078657423SPEED GUNAngelus Industria de Produtos Odontologicos S AEKI2025-03-20
07898078659427EdgeUtopia RRM Dispensing GunAngelus Industria de Produtos Odontologicos S AEKI2025-03-20
00813677023063PDT, Inc.PDT, INC.EKI2024-07-02
00813677023087PDT, Inc.PDT, INC.EKI2024-07-02
00813677023070PDT, Inc.PDT, INC.EKI2024-07-01
00813677023124PDT, Inc.PDT, INC.EKI2024-06-27
00813677024978PDT, Inc.PDT, INC.EKI2024-06-27
00840105223160ZOLL DENTALZoll-DentalEKI2024-05-31
00840105223177ZOLL DENTALZoll-DentalEKI2024-05-31
00840105223184ZOLL DENTALZoll-DentalEKI2024-05-31
00840105223191ZOLL DENTALZoll-DentalEKI2024-05-31
00840105223207ZOLL DENTALZoll-DentalEKI2024-05-31
D105SKU1312510SurgiMac Surgimac LLCEKI2024-05-08
D105SKU131257H02SurgiMac Surgimac LLCEKI2024-04-22
D105SKU131257H13SurgiMac Surgimac LLCEKI2024-04-22
10889950142407Amalgam Carrier, Reg/MiniHU-FRIEDY MFG. CO., LLCEKI2024-04-02
10889950142414Amalgam Carrier, Reg/LrgHU-FRIEDY MFG. CO., LLCEKI2024-04-02
10889950142421Amalgam Carrier, Reg/JumboHU-FRIEDY MFG. CO., LLCEKI2024-04-02
10889950142438Amalgam WellHU-FRIEDY MFG. CO., LLCEKI2024-04-02
D105SKU1312550SurgiMac Surgimac LLCEKI2024-03-18
D105SKU1312551SurgiMac Surgimac LLCEKI2024-03-18
08800075626325OSUNG MNDOSUNG MND Co., Ltd.EKI2024-02-23
08800075603531OSUNG MNDOSUNG MND Co., Ltd.EKI2024-02-21