FDA.reportPublic FDA data

TBS BASICS

Primary DI
G149TBSB5160
Brand
TBS BASICS
Company
ACME ENTERPRISE.
Model
TBSB516
Catalog number
TBSB516
Device description
TBS BASICS Gracey Curette 7/8, #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
EMSCurette, Periodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMSCurette, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G149TBSB5160PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Manual dental scaler, reusableA hand-held dental instrument designed for removing calculus and other accretions from the surface and between the teeth during dental cleaning and periodontal (gum) therapy. It is typically designed as a one-piece instrument with a pointed, distal end of various shapes and sizes. Also known as a periodontic scaler, it can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. 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
G149TBSB5050TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5060TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5070TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5080TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5100TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5120TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5130TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5140TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5170TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5180TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5200TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5210TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5220TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5230TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5240TBS BASICSACME ENTERPRISE.EMS2026-05-20
G149TBSB5250TBS BASICSACME ENTERPRISE.EMS2026-05-20
EZPF2423001G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423001GM50HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423103G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423105G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423105GM50HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423105L0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423411G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423411GM50HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423415G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423507G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423507GM50HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423609G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423713G0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13
EZPF2423713GM50HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMS2026-04-13