FDA.reportPublic FDA data

LENTULO

Primary DI
07640142420439
Brand
LENTULO
Company
FKG Dentaire Sàrl
Model
02.171.25.S25.GM
Catalog number
02.171.25.S25.GM
Device description
Paste-Fillers, standard, 171, 25 mm, # 25-40, handle GM
Published
2022-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EIYInstrument, Filling, Plastic, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIYInstrument, Filling, Plastic, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640142420439PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640142420439076401424204397640142420439

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic obturation material distribution endpiece, reusableA dental endpiece designed to be attached to a dental power tool handpiece to distribute root canal sealer/cement/paste evenly throughout the root canal system typically by applying the material in a lateral direction. It is a thin metal rod with a spiral (e.g., Lentulo spiral type), helicoidal, or circular design. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
482884061
Device count
1
DM exempt
true
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
07640452461030EdgeGlidepathEGP0221HTS4EGP0221HTS42026-06-03
07640452461047EdgeGlidepathEGP0225HTSEGP0225HTS2026-06-03
07640452461054EdgeGlidepathEGP0231HTSEGP0231HTS2026-06-03
07640452461061EdgeOne FireEOF21ASSTEOF21ASST2026-06-03
07640452461078EdgeOne FireEOF25ASSTEOF25ASST2026-06-03
07640452461085EdgeOne FireEOF31ASSTEOF31ASST2026-06-03
07640452461092EdgeOne FireEOF21ASSTDEOF21ASSTD2026-06-03
07640452461108EdgeOne FireEOF25ASSTDEOF25ASSTD2026-06-03
07640452461115EdgeOne FireEOF31ASSTDEOF31ASSTD2026-06-03
07640452461122EdgeOne FireEOFLG21HTSEOFLG21HTS2026-06-03
07640452461139EdgeOne FireEOFLG25HTSEOFLG25HTS2026-06-03
07640452461146EdgeOne FireEOFLG31HTSEOFLG31HTS2026-06-03
07640452461153EdgeOne FireEOFMED21HTSEOFMED21HTS2026-06-03
07640452461160EdgeOne FireEOFMED25HTSEOFMED25HTS2026-06-03
07640452461177EdgeOne FireEOFMED31HTSEOFMED31HTS2026-06-03
07640452461184EdgeOne FireEOFPRI21HTSEOFPRI21HTS2026-06-03
07640452461191EdgeOne FireEOFPRI25HTSEOFPRI25HTS2026-06-03
07640452461207EdgeOne FireEOFPRI31HTSEOFPRI31HTS2026-06-03
07640452461214EdgeOne FireEOFSM21HTSEOFSM21HTS2026-06-03
07640452461221EdgeOne FireEOFSM25HTSEOFSM25HTS2026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB4010TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4020TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4030TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4040TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4050TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4060TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4070TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4080TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4140TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4150TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4200TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4210TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4220TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB8130TBS BASICSACME ENTERPRISE.EIY2026-05-18
G149TBSB8010TBS BASICSACME ENTERPRISE.EIY2026-05-17
G149TBSB8020TBS BASICSACME ENTERPRISE.EIY2026-05-17
G149TBSB8030TBS BASICSACME ENTERPRISE.EIY2026-05-17
G149TBSB8040TBS BASICSACME ENTERPRISE.EIY2026-05-17
G149NPBPT0NPSACME ENTERPRISE.EIY2026-05-01
08800075626134OSUNG MNDOSUNG MND Co., Ltd.EIY2025-11-03
07649988072451OdneFill TipOdne AGEIY2024-02-01
10889950005283HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12
10889950005290HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12
10889950005306HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12
10889950005313HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12
10889950005320HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12
10889950005337HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12
10889950005344HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12
10889950005351HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12
10889950005368HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12