FDA.reportPublic FDA data

ZOLL-DENTAL

Primary DI
00840105205678
Brand
ZOLL-DENTAL
Company
Zoll-Dental
Model
LCT-1
Device description
LCT-1 Laser Cleaving Tool
Published
2021-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJZKNIFE, MARGIN FINISHING, OPERATIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJZKnife, Margin Finishing, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840105205678PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840105205678008401052056788401052056780840105205678

GMDN Terms#

Term, Definition table
TermDefinition
Margin finishing dental file/rasp, reusableA hand-held manual dental instrument that has various forms of fine ridged cutting surfaces at its working end(s) designed to smooth and shape a tooth, an approximate bone (e.g., alveolar) and/or a dental restoration (e.g., filling). It is typically a one-piece instrument available in a variety of sizes and working end designs, including straight and curved ends, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(847)647-1819JEFF@ZOLLDENTAL.COM

Regulatory Flags#

DUNS number
005449822
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
00840105223801ZOLL DENTALZ-49352025-08-11
00840105223757ZOLL DENTALGK-TUN-K62025-08-06
00840105223764ZOLL DENTALGK-TUN-K72025-08-06
00840105223771ZOLL DENTALGK-TUN-K82025-08-06
00840105223788ZOLL DENTALGK-TUN-K92025-08-06
00840105223795ZOLL DENTALGK-TUN-K102025-08-06
00840105223740ZOLL DENTALZ-99972025-07-24
00840105223733ZOLLDENTALS-ST22025-03-17
00840105223726ZOLL DENTALZ-73012025-01-29
00840105223672ZOLL DENTALZ-13022024-12-18
00840105223689ZOLL DENTALZ-13032024-12-18
00840105223696ZOLL DENTALZ-47862024-12-18
00840105223702ZOLL DENTALZ-47872024-12-18
00840105223719ZOLL DENTALZ-47902024-12-18
00840105223658ZOLL DENTALZ-52585052024-12-11
00840105223665ZOLL DENTALZ-48205052024-12-11
00840105223641ZOLL DENTALZ-49862024-08-26
00840105223634ZOLL DENTALRET-UofMN-BENT2024-08-01
00840105223573ZOLL DENTALZ-49332024-07-29
00840105223597ZOLL DENTALZ-90322024-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800075604484OSUNG MNDOSUNG MND Co., Ltd.EJZ2024-02-26
08800075604460OSUNG MNDOSUNG MND Co., Ltd.EJZ2024-02-19
08800075604477OSUNG MNDOSUNG MND Co., Ltd.EJZ2024-02-19
08800075604491OSUNG MNDOSUNG MND Co., Ltd.EJZ2024-02-19
10889950110512Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-07-19
10889950110529Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-07-19
10889950121204Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-06-27
10889950043360Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-04-07
10889950043377Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-04-07
10889950080662Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-04-07
10889950080679Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-04-07
D943G18010GargPower Dental U.S.A. Inc.EJZ2023-02-28
D943G18120GargPower Dental U.S.A. Inc.EJZ2023-02-28
10889950139353Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950139360Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950139414Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950139421Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950139438Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950139513Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950044251HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2022-01-20
10889950133153Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2021-10-08
D9431816D0Power Dental USAPower Dental U.S.A. Inc.EJZ2021-07-13
D9431812M00Power Dental USAPower Dental U.S.A. Inc.EJZ2021-07-13
D9431816D00Power Dental USAPower Dental U.S.A. Inc.EJZ2021-07-13
D9431812L00Power Dental USAPower Dental U.S.A. Inc.EJZ2021-07-13
D943N1812L00Power Dental U.S.A., Inc.Power Dental U.S.A. Inc.EJZ2021-07-13
D943N1812M00Power Dental U.S.A., Inc.Power Dental U.S.A. Inc.EJZ2021-07-13
D943N1816D00Power Dental U.S.A., Inc.Power Dental U.S.A. Inc.EJZ2021-07-13
D94318020Power Dental USAPower Dental U.S.A. Inc.EJZ2021-06-20
D94318130Power Dental USAPower Dental U.S.A. Inc.EJZ2021-06-20