FDA.reportPublic FDA data

A-dec

Primary DI
10194665004460
Brand
A-dec
Company
A-DEC, INC.
Model
54.0865.00
Catalog number
54.0865.00
Device description
Electric LS Package,M20L,Master Matic,OTC
Published
2022-11-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EFBHandpiece, Air-Powered, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143465000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143465000MASTERmatic LUXKaltenbach & Voigt GmbH2015-04-09EFA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10194665004460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019466500446010194665004460

GMDN Terms#

Term, Definition table
TermDefinition
Barbed polyolefin sutureA single-strand (monofilament), synthetic, non-bioabsorbable thread made from a polyolefin (e.g., polypropylene) intended to approximate the edges of a soft-tissue wound or incision by stitching. It is designed with barbs along its length intended to facilitate tissue approximation by adding tension, a fixation feature (e.g., tab, loop, bidirectional barbs) to eliminate the need to tie a knot, and may include disposable suture application devices [e.g., needle, passer]. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, after which it is cut and removed. It does not include antimicrobial materials. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
009617473
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10194665008857A-decS76S762026-05-07
10194665008918A-dec397pb397pb2026-06-22
10194665008444A-dec54.0924.0154.0924.012026-02-19
10194665008475A-dec54.1073.0054.1073.002026-02-19
10194665008482A-dec54.1073.0154.1073.012026-02-19
10194665008499A-dec54.1074.0054.1074.002026-02-19
10194665008505A-dec54.1074.0154.1074.012026-02-19
10194665008512A-dec54.1051.0054.1051.002026-02-19
10194665008529A-dec54.1052.0054.1052.002026-02-19
10194665008550A-dec54.1076.0054.1076.002026-02-19
10194665008697A-dec3453452026-02-17
10194665008666A-decAMDUWLAMDUWL2025-09-30
10194665008383A-dec311xlc311xlc2025-09-18
10194665006587A-dec311FLT311FLT2025-05-19
10194665006594A-dec511FLT511FLT2025-05-19
10194665007935ActeonC202025-05-15
10194665008321A-decNo Version or Model Number54.1042.002025-05-15
10194665008345A-decNo Version or Model Number54.1043.002025-05-15
10194665007928A-dec 54.1041.0054.1041.002025-02-11
10194665007911A-dec346134612025-01-24

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Primary DI, Brand, Company table
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D950133832360Xtreme PowerLARES RESEARCHEFB2026-09-04
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D950133852360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133902360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133912360Xtreme PowerLARES RESEARCHEFB2026-09-04
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D950133932360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133942360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133952360Xtreme PowerLARES RESEARCHEFB2026-09-04
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D950134812360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134822360Xtreme PowerLARES RESEARCHEFB2026-09-04
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D950134842360Xtreme PowerLARES RESEARCHEFB2026-09-04
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D950134902360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134912360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134922360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134932360Xtreme PowerLARES RESEARCHEFB2026-09-04
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D950134952360Xtreme PowerLARES RESEARCHEFB2026-09-04
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