FDA.reportPublic FDA data

StarDental Instrument Solutions

Primary DI
D7022027330
Brand
StarDental Instrument Solutions
Company
DENTALEZ, INC.
Model
202733
Device description
INSTR MG DE JACQ 2YS-3YS
Published
2018-11-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMNScaler, Periodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMNScaler, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D7022027330PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
1-866-383-4636xx@xx.xx

Regulatory Flags#

DUNS number
059010363
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Contains natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D7022666500StarDental2666502666502026-04-22
D7022666510StarDental2666512666512026-04-22
D7022666520StarDental2666522666522026-04-22
D7022666530StarDental2666532666532026-04-22
D7022663420StarDental2663422663422025-06-20
D7022663430StarDental2663432025-06-20
D7022663450StarDental2663452025-06-20
D7022664900StarDental2664902025-06-20
D7022601520StarDental Instrument Solutions2601522018-11-05
D702RT3001050StarDental Instrument SolutionsRT3-001052016-09-13
D7022656330StarDental Instrument Solutions2656332018-11-05
D7022639480StarDental Instrument Solutions2639482018-11-05
D7022658060StarDental Instrument Solutions2658062018-11-05
D702RT3001130StarDental Instrument SolutionsRT3-001132016-09-12
D702RT3220000StarDental Instrument SolutionsRT3-220002016-09-12
D7022688600StarDental Instrument Solutions2688602018-11-05
D7022656300StarDental Instrument Solutions2656302018-11-05
D7022656340StarDental Instrument Solutions2656342018-11-05
D7022658210StarDental Instrument Solutions2658212018-11-05
D7022658220StarDental Instrument Solutions2658222018-11-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G149TBSB5020TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5030TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5040TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5110TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5150TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5190TBS BASICSACME ENTERPRISE.EMN2026-05-20
EZPF2423804S0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMN2026-04-13
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EZPF2423823A0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMN2026-04-13
08800075614841OSUNG MNDOSUNG MND Co., Ltd.EMN2025-11-03
07898506810871QuinelatoSchobell Industrial LtdaEMN2023-01-09
07898506810888QuinelatoSchobell Industrial LtdaEMN2023-01-09
EZPFKS242880HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMN2022-12-16
08800000981444Metal ScalerOsstem Implant Co., Ltd.EMN2022-12-08
08800000981451Metal ScalerOsstem Implant Co., Ltd.EMN2022-12-08
08800000981468Metal ScalerOsstem Implant Co., Ltd.EMN2022-12-08
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