FDA.reportPublic FDA data

TBS BASICS

Primary DI
G149TBSB4090
Brand
TBS BASICS
Company
ACME ENTERPRISE.
Model
TBSB409
Catalog number
TBSB409
Device description
TBS BASICS Burnisher, #27/31, #9 Hollow Handle
Published
2026-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
G149TBSB4090PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Manual dental burnisher, reusableA hand-held manual dental device with a smooth or ribbed working head intended to be used to create thin margins between a dental restoration and the enamel at the cavo-surface angle, and/or to polish the surface of metallic restorations by rubbing. Its terminus is round or ball-shaped and is typically made of metal. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
645459892
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
G149TBSB71000TBS BASICSTBSB7100TBSB71002026-05-22
G149TBSB71010TBS BASICSTBSB7101TBSB71012026-05-22
G149TBSB71020TBS BASICSTBSB7102TBSB71022026-05-22
G149TBSB71030TBS BASICSTBSB7103TBSB71032026-05-22
G149TBSB71040TBS BASICSTBSB7104TBSB71042026-05-22
G149TBSB71050TBS BASICSTBSB7105TBSB71052026-05-22
G149TBSB71060TBS BASICSTBSB7106TBSB71062026-05-22
G149TBSB71070TBS BASICSTBSB7107TBSB71072026-05-22
G149TBSB71080TBS BASICSTBSB7108TBSB71082026-05-22
G149TBSB71090TBS BASICSTBSB7109TBSB71092026-05-22
G149TBSB71100TBS BASICSTBSB7110TBSB71102026-05-22
G149TBSB71110TBS BASICSTBSB7111TBSB71112026-05-22
G149TBSB71120TBS BASICSTBSB7112TBSB71122026-05-22
G149TBSB71130TBS BASICSTBSB7113TBSB71132026-05-22
G149TBSB71140TBS BASICSTBSB7114TBSB71142026-05-22
G149TBSB71150TBS BASICSTBSB7115TBSB71152026-05-22
G149TBSB71160TBS BASICSTBSB7116TBSB71162026-05-22
G149TBSB71170TBS BASICSTBSB7117TBSB71172026-05-22
G149TBSB71180TBS BASICSTBSB7118TBSB71182026-05-22
G149TBSB71190TBS BASICSTBSB7119TBSB71192026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10889950007454HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12