FDA.reportPublic FDA data

TBS BASICS

Primary DI
G149TBSB2080
Brand
TBS BASICS
Company
ACME ENTERPRISE.
Model
TBSB208
Catalog number
TBSB208
Device description
TBS BASICS Endodontic Excavator, 33L, 2.0mm, #9 Hollow Handle
Published
2026-05-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EKTCurette, Endodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKTCurette, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G149TBSB2080PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental excavator, reusableA hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. 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
G149TBSB2060TBS BASICSACME ENTERPRISE.EKT2026-05-16
G149TBSB2070TBS BASICSACME ENTERPRISE.EKT2026-05-16
G149TBSB2090TBS BASICSACME ENTERPRISE.EKT2026-05-16
00810123209682Adler Instrument CompanyAdler, Inc.EKT2025-12-08
00190776410643MillenniumAvalign Technologies, Inc.EKT2025-09-11
00190776409166MillenniumAvalign Technologies, Inc.EKT2025-08-22
00190776405304MillenniumAvalign Technologies, Inc.EKT2025-07-15
00810123208340Adler Instrument CompanyAdler, Inc.EKT2025-01-27
00614950031405ACEACE SURGICAL SUPPLY CO., INC.EKT2023-12-05
00190776075002AvalignAvalign Technologies, Inc.EKT2023-11-13
00190776075019AvalignAvalign Technologies, Inc.EKT2023-09-28
00190776287412AvalignAvalign Technologies, Inc.EKT2023-09-28
00190776287429AvalignAvalign Technologies, Inc.EKT2023-09-28
00190776287436AvalignAvalign Technologies, Inc.EKT2023-09-28
00190776287498AvalignAvalign Technologies, Inc.EKT2023-09-28
00190776351359MILLENNIUMAvalign Technologies, Inc.EKT2023-09-28
00190776372606AvalignAvalign Technologies, Inc.EKT2023-09-28
00810123202362Adler Instrument CompanyAdler, Inc.EKT2023-03-16
00190776363277MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363284MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363291MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363307MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363314MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363321MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363338MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363345MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363352MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363369MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363376MillenniumAvalign Technologies, Inc.EKT2023-02-22
00190776363383MillenniumAvalign Technologies, Inc.EKT2023-02-22