FDA.reportPublic FDA data

NA

Primary DI
04963931271290
Brand
NA
Company
YDM CORPORATION
Model
27129
Catalog number
27129
Device description
The device is an instrument used when treating patients with reinfected root canal to remove gutta percha, etc. attached to the root canal walls.
Published
2026-07-09
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
EMNScaler, Periodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMNScaler, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04963931271290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04963931271290049639312712904963931271290

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
+819019940653jumpei@ydm.co.jp

Regulatory Flags#

DUNS number
716059766
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
04963931271214NA27121271212026-07-09
04963931271221NA27122271222026-07-09
04963931271238NA27123271232026-07-09
04963931271245NA27124271242026-07-09
04963931271252NA27125271252026-07-09
04963931271269NA27126271262026-07-09
04963931271276NA27127271272026-07-09
04963931271283NA27128271282026-07-09
04963931271306NA27130271302026-07-09
04963931210794NA21079210792025-12-05
04963931210800NA21080210802025-12-05
04963931274291NA27429274292025-07-11
04963931274659NA27465274652025-04-03
04963931274666NA27466274662025-04-03
04963931227211NA22721227212024-04-01
04963931227228NA22722227222024-04-01
04963931227266NA22726227262024-04-01
04963931276103NA27610276102024-04-01
04963931102013NA10201102012024-02-08
04963931102020NA10202102022024-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04963931271214NAYDM CORPORATIONEMN2026-07-09
04963931271221NAYDM CORPORATIONEMN2026-07-09
04963931271238NAYDM CORPORATIONEMN2026-07-09
04963931271245NAYDM CORPORATIONEMN2026-07-09
04963931271252NAYDM CORPORATIONEMN2026-07-09
04963931271269NAYDM CORPORATIONEMN2026-07-09
04963931271276NAYDM CORPORATIONEMN2026-07-09
04963931271283NAYDM CORPORATIONEMN2026-07-09
04963931271306NAYDM CORPORATIONEMN2026-07-09
G149TBSB5010TBS BASICSACME ENTERPRISE.EMN2026-05-20
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
EZPF2423804SD0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMN2026-04-13
EZPF2423806HF0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMN2026-04-13
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
ESAM12718001STOMA®Storz am Mark GmbHEMN2020-08-27
ESAM12718101STOMA®Storz am Mark GmbHEMN2020-08-27
ESAM12720101STOMA®Storz am Mark GmbHEMN2020-08-27