FDA.report

Karl Schumacher

Primary DI
00842517119321
Brand
Karl Schumacher
Company
Karl Schumacher Dental, LLC
Model
SCA6260
Device description
Jaquette 2/3 Post Scaler
Published
2024-05-06
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

Related Records

Contact Domains

Product Codes

CodeName
ELAINSTRUMENT, HAND, CALCULUS REMOVAL

Product Code Classifications

CodeDeviceSpecialtyClass
ELAInstrument, Hand, Calculus RemovalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842517119321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842517119321008425171193218425171193210842517119321

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)523-2427custsvs@karlschumacher.com

Regulatory Flags

DUNS number
101070070
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 DIBrandModelCatalogPublished
00842517104747Karl SchumacherASP0016T2025-07-08
00842517112360Karl SchumacherNEE00022025-07-08
00842517112384Karl SchumacherNEE00062025-07-08
00842517112421Karl SchumacherNEE00082025-07-08
00842517112438Karl SchumacherNEE0008T2025-07-08
00842517112476Karl SchumacherNEE00112025-07-08
00842517112483Karl SchumacherNEE00122025-07-08
00842517116764Karl SchumacherSCI0667S2025-06-19
00842517104129Karl SchumacherASP0000Y2025-04-23
00842517112568Karl SchumacherNEE06862025-04-23
00842517112582Karl SchumacherNEE06892025-04-23
00842517112599Karl SchumacherNEE06902025-04-23
00842517112629Karl SchumacherNEE06912025-04-23
00842517112780Karl SchumacherNEE07902025-04-23
00842517112803Karl SchumacherNEE07912025-04-23
00842517111417Karl SchumacherHEM06102025-02-05
00842517111424Karl SchumacherHEM06112025-02-05
00842517112209Karl SchumacherMOS06122025-02-05
00842517112216Karl SchumacherMOS06132025-02-05
00842517103603Karl SchumacherAMCBGMS2024-09-19

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840018674530Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-14
00840018674417Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-12
00840018674424Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-12
00840018674431Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-12
00840018674455Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-12
00840018674462Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-12
00840018674479Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-12
00840018674523Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-12
00840018674363Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-11
00840018674387Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-11
00840018674394Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-11
00840018674400Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-11
00840018674233Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-02
00840018674240Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-03-02
00840018672918Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
00840018673854Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
00840018673861Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
00840018673878Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
00840018673885Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
00840018673892Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
00840018673991Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
00840018674004Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
00840018674066Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
00840018674073Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
00840018674080Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
00840018674110Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
00840018674196Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
00840018674202Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-11
10810132809443House Brand DentistryFrontier Dental Supply IncELA2026-02-10
00840018667266Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCELA2026-02-10