FDA.reportPublic FDA data

ZOLL-DENTAL

Primary DI
00840105215714
Brand
ZOLL-DENTAL
Company
Zoll-Dental
Model
Z-11TKP
Device description
Crown Scissors, Pedo Large Curved 11cm
Published
2021-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIRSCISSORS, COLLAR AND CROWN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIRScissors, Collar And CrownDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840105215714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840105215714008401052157148401052157140840105215714

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis removerA non-electric, hand-held dental instrument intended to be used to remove a permanent or temporary cemented dental prosthesis restoration (e.g., crown, denture, bridge) from a tooth or implant abutment; it is not a thermal detacher. It consists of a metallic instrument with a handle and a pointed, angled distal end used to secure the instrument at the margin of the prosthesis to be removed; it may be designed as a manual, pneumatic or spring-loaded instrument whereby light force is applied to detach the restoration. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840105223009ZOLL DENTALSYR-4962-22023-07-11
00840105223818ZOLL DENTALZ-49342025-09-16
00840105223825ZOLL DENTALZ-49362025-09-16
00840105223832ZOLL DENTALZ-49372025-09-16
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
00840105215226ZOLL-DENTALZ-10TKP2021-03-10
00840105215967ZOLL-DENTALZ-12TKP2021-03-10
00840105216131ZOLL-DENTALZ-19-274-13-P2021-03-10
00840105216148ZOLL-DENTALZ-19-274-13-T2021-03-10
00840105216155ZOLL-DENTALZ-19-274-162021-03-10
00840105218388ZOLL-DENTALZ-44382021-03-10
00840105220268ZOLL-DENTALZ-71451-002021-03-10
00840105220275ZOLL-DENTALZ-71451-012021-03-10
00840105220282ZOLL-DENTALZ-71451-022021-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB71150TBS BASICSACME ENTERPRISE.EIR2026-05-22
G149TBSB71160TBS BASICSACME ENTERPRISE.EIR2026-05-22
D758SC00110RIBBOND SCISSORSRIBBOND, INCEIR2025-06-27
00359883003043Clinician's Choice® Micropoint ScissorsDEN-MAT HOLDINGS, LLCEIR2025-03-12
D105SKU1626020SurgiMac Surgimac LLCEIR2024-04-22
D105SKU1626030SurgiMac Surgimac LLCEIR2024-04-22
D105SKU1626021SurgiMac Surgimac LLCEIR2024-04-22
D105SKU1626031SurgiMac Surgimac LLCEIR2024-04-22
G586G92536210Novo SurgicalNOVO SURGICAL, INC.EIR2024-03-13
G586G2535230Novo SurgicalNOVO SURGICAL, INC.EIR2023-12-18
00841336101920Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIR2023-08-10
D758II0Ribbond ScissorsRIBBOND, INCEIR2023-07-20
00810059291683Denovo Dental stainless steel Crowns Scissors - assortmentDenovo Dental, Inc.EIR2023-06-30
00810059291690Denovo Dental Crown Scissors Denovo Dental, Inc.EIR2023-06-30
00810059291706Denovo Dental Crown Scissors Denovo Dental, Inc.EIR2023-06-30
00810059291713Denovo Dental Crown Scissors Denovo Dental, Inc.EIR2023-06-30
00840183520038BR Surgical, LLCBR Surgical, LLCEIR2023-04-26
D127242135A1Artman Instruments Wise Linkers, LLCEIR2023-03-29
D127EUDODZO1SX1Artman Instruments Wise Linkers, LLCEIR2023-03-29
E89648690SCHWERTA. Schweickhardt GmbH & Co. KGEIR2023-02-23
EZPF46683090HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEIR2022-12-16
EZPF46687100HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEIR2022-12-16
306058610691143M™3M COMPANYEIR2022-12-08
306058610691213M™3M COMPANYEIR2022-12-08
00887919414032Brasseler USAPeter Brasseler Holdings, LLCEIR2022-12-08
00887919414049Brasseler USAPeter Brasseler Holdings, LLCEIR2022-12-08
EZPF46674100HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEIR2022-12-07
EZPF46675100HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEIR2022-12-07
EZPF46685120HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEIR2022-12-07
EZPF4688512TC0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEIR2022-12-07