FDA.reportPublic FDA data

ZOLL-DENTAL

Primary DI
00840105218302
Brand
ZOLL-DENTAL
Company
Zoll-Dental
Model
Z-4395
Device description
Brewer Rubber Dam Forceps
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
EJGFORCEPS, RUBBER DAM CLAMP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJGForceps, Rubber Dam ClampDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840105218302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840105218302008401052183028401052183020840105218302

GMDN Terms#

Term, Definition table
TermDefinition
Rubber dam clamp forcepsA hand-held dental instrument used for the insertion and removal of rubber dam clamps. It is typically designed with permanently joined handles pivoted scissor-like, and has small projections at the working end that fit into corresponding holes in the rubber dam clamp. It will typically have a sliding lock mechanism that locks the handles in position while the operator moves the rubber dam clamp around the tooth. 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
08800019151012BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151029BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151036BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151043BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151050BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151067BL Clamp B& L Biotech, inc.EJG2025-07-18
07899798207721QuinelatoSchobell Industrial LtdaEJG2025-02-27
00889813063583Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEJG2024-11-30
00348783001488Premier Rubber Dam PunchPREMIER DENTAL PRODUCTS COMPANYEJG2024-08-01
00813677023315PDT, Inc.PDT, INC.EJG2024-06-27
00813677023322PDT, Inc.PDT, INC.EJG2024-06-27
00348783010602Premier Rubber Dam ClampPREMIER DENTAL PRODUCTS COMPANYEJG2024-04-10
D9495000821Bioclear InstrumentBioclear Matrix SystemsEJG2024-04-05
08800075603449OSUNG MNDOSUNG MND Co., Ltd.EJG2024-02-23
08964003163532NivoB. Ali ImpexEJG2024-01-29
08964003163600Doctor NiceB. Ali ImpexEJG2024-01-29
08964003163273NivoB. Ali ImpexEJG2024-01-27
D9495000813Bioclear InstrumentBioclear Matrix SystemsEJG2023-09-11
D9495000811Bioclear InstrumentBioclear Matrix SystemsEJG2023-08-10
05055382843894DentalTIMESCO HEALTHCARE LIMITEDEJG2023-07-06
00840105222866ZOLL DENTALZoll-DentalEJG2023-04-20
07630392900393HysolateDent4You AGEJG2023-02-28
EZPF19010000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJG2022-11-29
EZPF19015000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJG2022-11-29
EZPF19015500HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJG2022-11-29
EZPF19037010HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJG2022-11-29
EZPF19125000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJG2022-11-29
07898506811823QuinelatoSchobell Industrial LtdaEJG2022-10-24
00810060722541Rubber dam forceps Berman Instruments LLCEJG2022-09-21
00810038090429Composi-Tight®GARRISON DENTAL SOLUTIONS, L.L.C.EJG2022-08-31