FDA.reportPublic FDA data

Surgical Direct

Primary DI
B382SD25090
Brand
Surgical Direct
Company
Surgical Direct, Inc.
Model
SD2509
Catalog number
SD2509
Device description
Cleoid Discoid CD1/2
Published
2026-10-15
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
EKJBurnisher, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKJBurnisher, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B382SD25090PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental restoration carver, amalgam, reusableA hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental amalgam restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 519-3293info@surgicaldirect.com

Regulatory Flags#

DUNS number
124367223
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
B382SD23170Surgical DirectSD2317SD23172026-10-15
B382SD379410Surgical DirectSD37941SD379412026-10-15
B382SD4830070Surgical DirectSD48-3007SD48-30072026-10-15
B382SD4840320Surgical DirectSD48-4032SD48-40322026-10-15
B382SD48800050Surgical DirectSD48-80005SD48-800052026-10-15
B382SD491118030Surgical DirectSD49-111803SD49-1118032026-08-04
B382SD62371520Surgical DirectSD62-37152SD62-371522026-10-15
B382SD717510050Surgical DirectSD7175-1005SD7175-10052026-10-15
B382SD9025151020Surgical DirectSD902515102SD9025151022026-10-15
B382SD903223060Surgical DirectSD90322306SD903223062026-10-15
B382SD903454040Surgical DirectSD90345404SD903454042026-10-15
B382SD903454060Surgical DirectSD90345406SD903454062026-10-15
B382SD911434070Surgical DirectSD91143407SD911434072026-10-15
B382SD914174550Surgical DirectSD91417455SD914174552026-10-15
B382SD9141781090Surgical DirectSD914178109SD9141781092026-10-15
B382SD9141781620Surgical DirectSD914178162SD9141781622026-10-15
B382SD914603200Surgical DirectSD91460320SD914603202026-10-15
B382SD920761000Surgical DirectSD92076100SD920761002026-10-15
B382SD1802S90Surgical DirectSD1802S9SD1802S92026-10-13
B382SD18146S90Surgical DirectSD18146S9SD18146S92026-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD23170Surgical DirectSurgical Direct, Inc.EKJ2026-10-15
B382SD28020Surgical DirectSurgical Direct, Inc.EKJ2026-07-31
00850083275655Intrace USAPILOTIS TECH LLCEKJ2026-07-03
00348783009361Premier BurnisherPREMIER DENTAL PRODUCTS COMPANYEKJ2026-03-17
10889950147372Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147389Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147716Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147747Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147754Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147761Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147792Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147884Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147914Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950148065Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950148102Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
00841013120435American Eagle Instruments, Inc.AMERICAN EAGLE INSTRUMENTS, INC.EKJ2025-02-18
00841013120442American Eagle Instruments, Inc.AMERICAN EAGLE INSTRUMENTS, INC.EKJ2025-02-18
07898506811656QuinelatoSchobell Industrial LtdaEKJ2022-12-08
07898506843459QuinelatoSchobell Industrial LtdaEKJ2022-12-08
00841013101892American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-07-24
00841013102059American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-07-24
00841013109607American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-07-24
00841013101878American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-05-23
00841013101908American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-05-23
00841013101915American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-05-23
00841013101922American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-05-23
00841013101939American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-05-23
00841013101946American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-05-23
00841013101953American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-05-23
00841013102004American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-05-23