FDA.reportPublic FDA data

Darby Dental Supply, LLC

Primary DI
00889813014196
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
9430820
Catalog number
9430820
Device description
3 STEP ZIRCONIA REVEAL-PT 3.3 DARBY
Published
2018-05-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EHMSTRIP, POLISHING AGENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHMStrip, Polishing AgentDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889813014196PrimaryGS10
00889813014189Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813014196008898130141968898130141960889813014196
00889813014189008898130141898898130141890889813014189

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive point, reusableA rotary endpiece designed to be attached to a dental power tool handpiece to produce an abrasive rotation typically for polishing and smoothing natural or restorative dental materials (e.g., crown) during a dental procedure. Also referred to as a polisher, it is available in various forms (e.g., conical), sizes, and materials [e.g., silicone, rubber, metal, diamond, silicon carbide, aluminium oxide]. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(516)688-6800Robyn.livingston@darby.com

Regulatory Flags#

DUNS number
825137818
Device count
6
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889813067970Darby Dental Supply, LLC95377462026-03-22
00889813067987Darby Dental Supply, LLC95377502026-03-22
00889813067994Darby Dental Supply, LLC525879552587952026-02-12
00889813068007Darby Dental Supply, LLC525879652587962026-02-12
00889813068021Darby Dental Supply, LLC525879752587972026-02-12
00889813068038Darby Dental Supply, LLC525879852587982026-02-12
00889813068045Darby Dental Supply, LLC525879952587992026-02-12
00889813068052Darby Dental Supply, LLC525879052587902026-02-12
00889813068069Darby Dental Supply, LLC525879152587912026-02-12
00889813068076Darby Dental Supply, LLC525879252587922026-02-12
00889813068083Darby Dental Supply, LLC525879352587932026-02-12
00889813068090Darby Dental Supply, LLC525879452587942026-02-12
00889813048566Darby Dental Supply, LLC943020394302032022-07-18
00889813048580Darby Dental Supply, LLC943020494302042022-07-18
00889813048610Darby Dental Supply, LLC943020594302052022-07-18
00889813048672Darby Dental Supply, LLC943021094302102022-07-18
00889813048696Darby Dental Supply, LLC943021194302112022-07-18
00889813048719Darby Dental Supply, LLC943021294302122022-07-18
00889813048443Darby Dental Supply, LLC943020294302022022-07-18
00889813048511Darby Dental Supply, LLC943020194302012022-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ESUN3048Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46708Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46718Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46728Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46738Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46748Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46768Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46778Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46808Jiffy proximal sawDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46838Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3541008Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF354L8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF354LD8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3568Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF356L8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3638Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3648Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3668Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF37258Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3725BULK5008Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3725LW8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3738Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF373D8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3748Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF374BULK5008Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF374D8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF374LW8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3768Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF376D8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNG30450MM8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30