FDA.report

STOMA®

Primary DI
ESAM14612000
Brand
STOMA®
Company
Storz am Mark GmbH
Model
14612.00
Catalog number
14612.00
Device description
Bone applicator, LP1
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
DZNINSTRUMENTS, DENTAL HAND

Product Code Classifications

CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
ESAM14612000Direct MarkingHIBCC0
ESAM14612001PrimaryHIBCC0

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

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
06438311708676LMDentalLM-DentalDZN2026-03-23
06438311708683LMDentalLM-DentalDZN2026-03-23
06438311708690LMDentalLM-DentalDZN2026-03-23
06438311708706LMDentalLM-DentalDZN2026-03-23
06438311708713LMDentalLM-DentalDZN2026-03-23
06438311708720LMDentalLM-DentalDZN2026-03-23
06438311708737LMDentalLM-DentalDZN2026-03-23
06438311708744LMDentalLM-DentalDZN2026-03-23
06438311708751LMDentalLM-DentalDZN2026-03-23
06438311708768LMDentalLM-DentalDZN2026-03-23
00348783008807Premier Cord PackersPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783008890Premier Cord PackersPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783009552Premier SpatulaPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783009569Premier SpatulaPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783009859Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783009897Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00348783009903Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANYDZN2026-03-17
00840479202594RELIABOX PRE-PASTED STORAGE BOXRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-03-11
00840479202600RELIABOX PRE-PASTED STORAGE BOXRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-03-11
00840479203119RELIABOX ANTERIOR BRACKET HOLDING TWEEZERSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-03-11
00840479203126RELIABOX POSTERIOR BRACKET HOLDING TWEEZERSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-03-11
10840481136013BULK EZZest Anchors, LLCDZN2026-03-10
00840479201054COMPOSITE FILLING INSTRUMENTSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-27
00840479201061COMPOSITE FILLING INSTRUMENTSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-27
00840479201078COMPOSITE FILLING INSTRUMENTSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-27
00840479201085COMPOSITE FILLING INSTRUMENTSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-27
00840479201092COMPOSITE FILLING INSTRUMENTSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-27
00840479201108COMPOSITE FILLING INSTRUMENTSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-27
00840479200750RELIAPRY ALIGNER REMOVAL TOOLRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-23
00840018667129Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCDZN2026-02-10