FDA.report

ZOLL-DENTAL

Primary DI
00840105200147
Brand
ZOLL-DENTAL
Company
Zoll-Dental
Model
ELE-190
Device description
#190
Published
2019-11-26
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

Related Records

Contact Domains

Product Codes

CodeName
GEGELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840105200147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840105200147008401052001478401052001470840105200147

GMDN Terms

TermDefinition
Dental root elevatorA hand-held manual dental instrument intended to be used as a lever during the extraction of a tooth or retained roots. It is typically a one-piece instrument with a strong but slender blade at the distal working end, or it may be double-ended with a central handle. It is available in a variety of sizes and blade designs and is pushed in between the gums and the tooth exterior to loosen the tissue surrounding the tooth. Sometimes this can be enough to loosen and extract the tooth without the use of other instruments. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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 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 DIBrandCompanyProduct codePublished
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00190776417987MillenniumAvalign Technologies, Inc.GEG2026-03-23
00190776417536MillenniumAvalign Technologies, Inc.GEG2026-02-27
B382SD9141051070Surgical DirectSurgical Direct, Inc.GEG2026-02-17
00190776416577MillenniumAvalign Technologies, Inc.GEG2026-02-16
B382SD62432250Surgical DirectSurgical Direct, Inc.GEG2026-02-16
B382SD9141051050Surgical DirectSurgical Direct, Inc.GEG2026-02-16
B382SD23020Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD23030Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD671050Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD6716050Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD9141051060Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD9141051080Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD9206611040Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD921316170Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD921381050Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD92263910000Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD9226411030Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD922658020Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD923862510Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD940111100Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD1467010200Surgical DirectSurgical Direct, Inc.GEG2026-02-06
B382SD481003700Surgical DirectSurgical Direct, Inc.GEG2026-02-06
B382SD48820100Surgical DirectSurgical Direct, Inc.GEG2026-02-06
G3831056WM853543SURJEXSURJEXGEG2026-01-31
00190776415501MillenniumAvalign Technologies, Inc.GEG2026-01-27
00810123209743Adler Instrument CompanyAdler, Inc.GEG2026-01-02
00841336106802Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGEG2025-12-22
00841336106819Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGEG2025-12-22
B382SD91010Surgical DirectSurgical Direct, Inc.GEG2025-12-02