FDA.report

STOMA®

Primary DI
ESAM5995000
Brand
STOMA®
Company
Storz am Mark GmbH
Model
5995.00
Catalog number
5995.00
Device description
Articulating paper tweezers
Published
2020-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EFKFORCEPS, ARTICULATION PAPER

Product Code Classifications

CodeDeviceSpecialtyClass
EFKForceps, Articulation PaperDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
ESAM5995000Direct MarkingHIBCC0
ESAM5995001PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental articulation paper forcepsA hand-held manual dental instrument designed for grasping and holding articulation paper during its application to a patient's oral cavity. It typically has a tweezers-like design with two conjoined blades with serrated tips at the working end. It is made of high-grade stainless steel and is available in various sizes. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+49746592600sam@stoma.de

Regulatory Flags

DUNS number
318268125
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
ESAM1000STOMA®1.00 1.00 2025-04-30
ESAM13309100STOMA®13309.1013309.102025-04-30
ESAM14060470STOMA®14060.4714060.472025-04-30
ESAM14061470STOMA®14061.4714061.472025-04-30
ESAM14065470STOMA®14065.4714065.472025-04-30
ESAM14089470STOMA®14089.4714089.472025-04-30
ESAM14094470STOMA®14094.4714094.472025-04-30
ESAM14446250STOMA®14446.2514446.252025-04-30
ESAM14621760STOMA®14621.7614621.762025-04-30
ESAM14762480STOMA®14762.4814762.482025-04-30
ESAM23053120STOMA®23053.1223053.122025-04-30
ESAM23080000STOMA®23080.0023080.002025-04-30
ESAM23080131STOMA®23080.1323080.132025-04-30
ESAM23080160STOMA®23080.1623080.162025-04-30
ESAM3840130STOMA®3840.133840.132025-04-30
ESAM3841130STOMA®3841.133841.132025-04-30
ESAM4028010STOMA®4028.014028.012025-04-30
ESAM6550400STOMA®6550.406550.402025-04-30
ESAM6551100STOMA®6551.106551.102025-04-30
ESAM14140470STOMA®14140.4714140.472025-04-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00889813066553Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFK2024-11-30
00813677022486PDT, Inc.PDT, INC.EFK2024-07-01
00842517103924Karl SchumacherKarl Schumacher Dental, LLCEFK2024-02-27
08800075603579OSUNG MNDOSUNG MND Co., Ltd.EFK2024-02-19
08964003163488NivoB. Ali ImpexEFK2024-01-29
08964003163662PREHMAB. Ali ImpexEFK2024-01-29
00310866002590NANOBYTEPASCAL COMPANY, INC.EFK2023-11-29
D040603000Forceps- PaperWHIP-MIX CORPORATIONEFK2023-08-18
07898506812141QuinelatoSchobell Industrial LtdaEFK2022-12-08
00887919408963Brasseler USAPeter Brasseler Holdings, LLCEFK2022-12-08
EZPF22100150HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEFK2022-11-30
EZPF22101150HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEFK2022-11-30
04963931270668NAYDM CORPORATIONEFK2022-09-30
04963931270675NAYDM CORPORATIONEFK2022-09-30
D77370010500Health-Tec/DHP Hand InstrumentsDental Health Products IncEFK2022-09-28
00850043381174Buffalo Dental MfgBuffalo Dental Manufacturing Co., Inc.EFK2022-08-05
00366975051059BENCOBENCO DENTAL SUPPLY CO.EFK2022-08-04
00366975051066BENCOBENCO DENTAL SUPPLY CO.EFK2022-08-04
G1577083000PomeePOMEE CORPORATIONEFK2022-01-04
G1577083050PomeePOMEE CORPORATIONEFK2022-01-04
G1577083100PomeePOMEE CORPORATIONEFK2022-01-04
D701ARPH2Articulating PaperPULPDENT CORPORATIONEFK2021-09-21
D701ARPS2Articulating PaperPULPDENT CORPORATIONEFK2021-09-21
D72310296083Safco Articulating Paper ForcepsSAFCO DENTAL SUPPLY CO.EFK2021-07-01
00840105217466ZOLL-DENTALZoll-DentalEFK2021-03-10
00840105217473ZOLL-DENTALZoll-DentalEFK2021-03-10
00840105217503ZOLL-DENTALZoll-DentalEFK2021-03-10
04560218667120DENTECHDENTECH CORPORATIONEFK2020-09-24
04560218667090DENTECHDENTECH CORPORATIONEFK2020-09-24
04560218667113DENTECHDENTECH CORPORATIONEFK2020-09-24