FDA.reportPublic FDA data

SCALER

Primary DI
00888118068255
Brand
SCALER
Company
KLS-Martin L.P.
Model
43-311-33-07
Device description
NO. 5/33
Published
2018-09-26
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
00888118068255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118068255008881180682558881180682550888118068255

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(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
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
00888118131782LEVEL ONE EXTREMITY26-066-60-092026-05-25
00888118131799LEVEL ONE EXTREMITY26-066-70-092026-05-25
00888118144928LEVEL ONE EXTREMITY26-950-40-072026-05-25
00888118145284PURE PECTUS24-070-60-092026-05-25
00888118145291PURE PECTUS24-070-62-092026-05-25
00888118150240PURE PECTUSCTM-241-100-012026-05-25
00888118150257PURE PECTUSCTM-241-101-012026-05-25
00888118150264PURE PECTUSCTM-241-200-012026-05-25
00888118150448IXOSCTM-263-100-012026-05-25
00888118150455IXOSCTM-263-101-012026-05-25
00888118150462IXOSCTM-263-202-012026-05-25
00888118150479IXOSCTM-263-202-022026-05-25
00888118150486IXOSCTM-263-202-032026-05-25
00888118150493IXOSCTM-263-202-042026-05-25
00888118150646IPS60-011-42-09-LP2026-05-25
00888118153029L1 STERNALCTM-242-302-012026-05-25
00888118153050IXOSCTM-263-203-012026-05-25
00888118153067IXOSCTM-263-203-022026-05-25
00888118153074IXOSCTM-263-203-032026-05-25
00888118153081IXOSCTM-263-203-042026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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