FDA.reportPublic FDA data

ZOLL-DENTAL

Primary DI
00840105206996
Brand
ZOLL-DENTAL
Company
Zoll-Dental
Model
OPCV-SP
Device description
Custom Finish (SP-XXXX)
Published
2020-03-13
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
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
00840105206996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840105206996008401052069968401052069960840105206996

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
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
00840105215714ZOLL-DENTALZ-11TKP2021-03-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB4090TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4100TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4110TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4120TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4130TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4280TBS BASICSACME ENTERPRISE.EKH2026-05-20
10889950005375HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005382HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005399HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005405HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005412HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005429HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005436HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005443HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005450HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005467HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005474HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005481HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005498HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005504HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005818HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950005825HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950006907HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950006914HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950006921HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950006938HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950007072HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950007423HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950007430HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
10889950007447HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12