FDA.reportPublic FDA data

LENTULO

Primary DI
07640142420354
Brand
LENTULO
Company
FKG Dentaire Sàrl
Model
02.171.21.030.GM
Catalog number
02.171.21.030.GM
Device description
Paste-Fillers, standard, 171, 21 mm, # 30, 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
OTC
false
Sterile
false
Single use
false

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
07640142420354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640142420354076401424203547640142420354

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
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640452465588Edge File X3X3170421HTSX3170421HTS2025-12-05
07640452465595Edge File X3X3200421HTSX3200421HTS2025-12-05
07640452465656Edge File X3X3170425HTSX3170425HTS2025-12-05
07640452465724Edge File X3X3170429HTSX3170429HTS2025-12-05
07640452465809Edge File X3X3200621HTSX3200621HTS2025-12-05
07640452465816Edge File X3X3250621HTSX3250621HTS2025-12-05
07640452465823Edge File X3X3300621HTSX3300621HTS2025-12-05
07640452465830Edge File X3X3400621HTSX3400621HTS2025-12-05
07640452465861Edge File X3X3200625HTSX3200625HTS2025-12-05
00764045246587Edge File X3X3250625HTSX3250625HTS2025-12-05
07640452465885Edge File X3X3300625HTSX3300625HTS2025-12-05
07640452465908Edge File X3X3400625HTSX3400625HTS2025-12-05
07640452466684Edge File X3X3170629HTSX3170629HTS2025-12-05
07640452465939Edge File X3X3200629HTSX3200629HTS2025-12-05
07640452465946Edge File X3X3250629HTSX3250629HTS2025-12-05
07640452465953Edge File X3X3300629HTSX3300629HTS2025-12-05
07640452465977Edge File X3X3400629HTSX3400629HTS2025-12-05
07640452466660Edge File X3X321ASSTX321ASST2025-12-05
07640452466677Edge File X3X325ASSTX325ASST2025-12-05
07640452466004EdgeSequel SapphireES04153021ASSTES04153021ASST2025-11-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817169029281Joy by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEIY2026-03-05
00840018672628Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-11
00840018667167Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-10
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00840018667464Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-10
00840018671768Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-10
00840018671775Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-10
00840018665675Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-09
00840018665804Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-09
00840018665811Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-09
00840018666047Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-09
00840018666085Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-09
00840018666993Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-09
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00840018663626Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-04
00840018663190Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-01-29
00840018663213Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-01-29
00840018661622Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-01-28
00840018661639Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-01-28
07649988629341OdneFill Tips 25mmOdne AGEIY2025-09-03
05010058178083InstrapacROBINSON HEALTHCARE LIMITEDEIY2025-06-23
05010058178694InstrapacROBINSON HEALTHCARE LIMITEDEIY2025-06-19
00303620001434Septodont Multi-Use DispenserSEPTODONT SAS SPECIALITES SEPTODONTEIY2025-05-29
00766054002987Turbo-CRESSENTIAL DENTAL SYSTEMS, INC.EIY2025-04-04
00889813066898Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEIY2025-03-12
00889813066904Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEIY2025-03-12
00889813066911Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEIY2025-03-12
00889813066928Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEIY2025-03-12
00889813066935Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEIY2025-03-12
00889813066942Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEIY2025-03-12