FDA.reportPublic FDA data

Darby Dental Supply, LLC

Primary DI
00889813036891
Brand
Darby Dental Supply, LLC
Company
DARBY DENTAL SUPPLY, LLC
Model
9430310
Catalog number
9430310
Device description
LUCAS CURETTE #85
Published
2020-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKECURETTE, OPERATIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKECurette, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889813036891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889813036891008898130368918898130368910889813036891

GMDN Terms#

Term, Definition table
TermDefinition
Margin finishing dental file/rasp, reusableA hand-held manual dental instrument that has various forms of fine ridged cutting surfaces at its working end(s) designed to smooth and shape a tooth, an approximate bone (e.g., alveolar) and/or a dental restoration (e.g., filling). It is typically a one-piece instrument available in a variety of sizes and working end designs, including straight and curved ends, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
825137818
Device count
1
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
D928105106HDHFDLC0CURETTE MOLT 2/4HD, HF D/E DLCW.H. Holden, Inc.EKE2026-01-06
D928105109JHF59DLC0CURETTE BONE #9J HF D/E SHORT HANDLE DLCW.H. Holden, Inc.EKE2026-01-06
D928105113CH0SINUS CURETTE D/E GOLEC CHW.H. Holden, Inc.EKE2025-02-06
D928105159CH0SINUS CURETTE K-N OBTUSE SMITH CH D/EW.H. Holden, Inc.EKE2024-12-18
D928105102HDFE0CURETTE MOLT #2HD EH-SM S/E **SPECIAL FLAT TIP**W.H. Holden, Inc.EKE2024-12-17
D928105104HO0CURETTE MOLT #4HD H/O HANDLEW.H. Holden, Inc.EKE2024-12-17
D92810510524RCH0CURETTE MOLT 2CH / 4HD, RIGHT, CH D/EW.H. Holden, Inc.EKE2024-12-17
D9281051066HFDLC0MOLT 4 DULL LEFT / RIGHT CURETTE, DLC, ACCORDING TO DR. CHANW.H. Holden, Inc.EKE2024-12-17
D928105109SHD0BONE CURETTE #9, STRAIGHT, 3.15mm /3.75MM, D/E SERRATED HDW.H. Holden, Inc.EKE2024-12-17
D92810511501HD0SINUS CURETTE B-2 MINI - CUSTOM INSTRUMENT HDW.H. Holden, Inc.EKE2024-12-17
D92810510524LCH0CURETTE MOLT 2CH / 4HD, LEFT, CH D/EW.H. Holden, Inc.EKE2024-12-03
D92810519916CH0CURETTE MOLT #4CH CH SPECIAL D/EW.H. Holden, Inc.EKE2024-12-03
D92810519916HF0CURETTE MOLT #4HD HF HANDLE SPECIAL D/EW.H. Holden, Inc.EKE2024-12-03
D928837102Z0BONE AUGMENTATION KIT ACC TO DR DANIEL CULLUMW.H. Holden, Inc.EKE2024-01-19
D928837151H0BONE TUNNELING KITW.H. Holden, Inc.EKE2024-01-19
D928837160H0LATERAL WINDOW SINUS CURETTE KIT ACC. TO DR. BART SILVERMANW.H. Holden, Inc.EKE2024-01-19
D9282007030ARNETT BONE CURETTEW.H. Holden, Inc.EKE2023-12-20
D9282007070ANTERIOR SINUS WALL CURETTEW.H. Holden, Inc.EKE2023-12-20
D928105102CH0CURETTE MOLT #2CH CH S/EW.H. Holden, Inc.EKE2023-10-10
D928105102CHE0CURETTE MOLT #2CH EH-SM S/EW.H. Holden, Inc.EKE2023-10-10
D928105102CHFE0CURETTE MOLT #2CH EH-SM S/E **SPECIAL FLAT TIP**W.H. Holden, Inc.EKE2023-10-10
D928105102CHHF0CURETTE MOLT #2CH HF S/EW.H. Holden, Inc.EKE2023-10-10
D928105102HD0CURETTE MOLT #2HD HD S/EW.H. Holden, Inc.EKE2023-10-10
D928105102HDE0CURETTE MOLT #2HD EH-SM S/EW.H. Holden, Inc.EKE2023-10-10
D928105102HDF0CURETTE MOLT #2HD HD S/E FLAT TIPW.H. Holden, Inc.EKE2023-10-10
D928105102HDH0CURETTE MOLT #2HD HF S/EW.H. Holden, Inc.EKE2023-10-10
D928105104CH0CURETTE MOLT #4CH CH S/EW.H. Holden, Inc.EKE2023-10-10
D928105104CHE0CURETTE MOLT #4CH EH-SM S/EW.H. Holden, Inc.EKE2023-10-10
D928105104CHLAKE0CURETTE MOLT #4CH CH SPECIAL D/EW.H. Holden, Inc.EKE2023-10-10
D928105104HD0CURETTE MOLT #4HD HD S/EW.H. Holden, Inc.EKE2023-10-10