FDA.reportPublic FDA data

ZOLL-DENTAL

Primary DI
00840105206958
Brand
ZOLL-DENTAL
Company
Zoll-Dental
Model
OPCV-Walls3
Device description
Walls #3
Published
2020-03-13
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
EKHCARVER, DENTAL AMALGAM, OPERATIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKHCarver, Dental Amalgam, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840105206958PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840105206958008401052069588401052069580840105206958

GMDN Terms#

Term, Definition table
TermDefinition
Dental amalgam carver, reusableA hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental amalgam restorations, typically for cutting, scraping, paring, and smoothing finishes and fashioning patterns. It will typically be a double-ended instrument made of high-grade stainless steel and have a solid blunt blade/nib of various sizes and designs with a central handle. 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
00348783009156Premier CarversPREMIER DENTAL PRODUCTS COMPANYEKH2026-03-17
00348783009231Premier CarversPREMIER DENTAL PRODUCTS COMPANYEKH2026-03-17
00840018674035Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKH2026-02-11
00840018674134Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKH2026-02-11
00840018674141Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKH2026-02-11
00840018674158Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKH2026-02-11
05010058180185InstrapacROBINSON HEALTHCARE LIMITEDEKH2025-06-23
00889813066058Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066065Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066089Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066096Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066102Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066119Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066126Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066133Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00889813066140Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKH2025-02-12
00841013116803American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKH2024-11-06
00813677025111PDT, Inc.PDT, INC.EKH2024-07-05
00813677021465PDT, Inc.PDT, INC.EKH2024-06-27
00842517106970Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517106987Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517106994Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517107007Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517107014Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517107021Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517107038Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517118225Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517118683Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517118690Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
00842517118706Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06