FDA.report

Wagotrix

Primary DI
00850028211366
Brand
Wagotrix
Company
GoldenDent
Model
WFCI1
Catalog number
WFCI1
Device description
Wagoform Titanium Coated Instrument #1
Published
2021-02-25
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

Product Codes

CodeName
EJBHANDLE, INSTRUMENT, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EJBHandle, Instrument, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850028211366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850028211366008500282113668500282113660850028211366

GMDN Terms

TermDefinition
Dental material application tool, reusableA hand-held manual dental instrument intended to be used for the application of a dental material (e.g., composite resin) to a dental prosthesis or to a patient’s tooth/teeth; the material is not included. It includes a handle with an application tip which holds the material on its surface; it is not a syringe- or pistol-like device. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
078273228
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
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 DIBrandModelCatalogPublished
00850011211939GoldenDentGO AGKGO AGK2021-02-26
00850011211946GoldenDentGO GKIGO GKI2021-02-26
00850011211014GoldenDentFS BFEFS BFE2021-02-25
00850011211021GoldenDentFS EF1FS EF12021-02-25
00850011211038GoldenDentFS EF2FS EF22021-02-25
00850011211045GoldenDentFS FSSFS FSS2021-02-25
00850011211052GoldenDentFS IA1FS IA12021-02-25
00850011211069GoldenDentFS IA2FS IA22021-02-25
00850011211076GoldenDentFS MTSFS MTS2021-02-25
00850011211083GoldenDentFS NCCFS NCC2021-02-25
00850011211090GoldenDentFS NCSFS NCS2021-02-25
00850011211106GoldenDentFS NTCFS NTC2021-02-25
00850011211113GoldenDentFS NTSFS NTS2021-02-25
00850011211120GoldenDentFS NUSFS NUS2021-02-25
00850011211137GoldenDentRS RFURS RFU2021-02-25
00850011211144GoldenDentFS SFCFS SFC2021-02-25
00850011211151GoldenDentFS TFUFS TFU2021-02-25
00850011211168GoldenDentGBSBGBSB2021-02-25
00850011211175GoldenDentGBSOGBSO2021-02-25
00850011211182GoldenDentGCCBGCCB2021-02-25

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00841013120459Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EJB2026-01-06
00841013120466Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EJB2026-01-06
30371347019668Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
30371347019675Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
30371347019682Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
30371347019699Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
00371347017724Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
00371347017748Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
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00883205032157Slide PackerULTRADENT PRODUCTS, INC.EJB2025-08-19
08806343925183ever KITShinhung MST Co., Ltd.EJB2025-07-28
08806343925213TAPER KITShinhung MST Co., Ltd.EJB2025-07-28
08806343925220GUIDE KITShinhung MST Co., Ltd.EJB2025-07-28
08057639710567Specialist OrganizerMC BIO SRLEJB2025-06-23
08057639710574Tip with Indexable StopMC BIO SRLEJB2025-06-23
08057639710598Offset Tip SPMC BIO SRLEJB2025-06-23
08057639710604Long Tip SPMC BIO SRLEJB2025-06-23
08057639710628GBR MODULAR SETMC BIO SRLEJB2025-06-23
08057639712066Handle - Straight MDFMC BIO SRLEJB2025-06-23
08057639712073Handle - Straight - ErgalMC BIO SRLEJB2025-06-23
08057639712080Handle - Straight SP (TiN)MC BIO SRLEJB2025-06-23
08057639712097Handle - Asym. - ErgalMC BIO SRLEJB2025-06-23
08057639712103Handle - Asym. - SP (TiN)MC BIO SRLEJB2025-06-23
08057639712110Handle - Asym. - TitaniumMC BIO SRLEJB2025-06-23
08056992093119Starter SetMC BIO SRLEJB2025-06-20
08056992093126Basic SetMC BIO SRLEJB2025-06-20
08056992093133Advance SetMC BIO SRLEJB2025-06-20
08806343922328Short Drill KitShinhung MST Co., Ltd.EJB2025-06-16