FDA.report

STOMA®

Primary DI
ESAM12965000
Brand
STOMA®
Company
Storz am Mark GmbH
Model
12965.00
Catalog number
12965.00
Device description
Periotome, bend-curved, Ø 8mm
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
EMOKNIFE, PERIODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EMOKnife, PeriodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
ESAM12965000Direct MarkingHIBCC0
ESAM12965001PrimaryHIBCC0

GMDN Terms

TermDefinition
Periotome, reusableA hand-held dental instrument used during tooth extraction to cut the periodontal ligament that binds the tooth to the surrounding marginal and alveolar bone (alveolar process). This procedure reduces the need for luxation of the tooth and minimizes mechanical trauma to the bone tissue. The device is typically made of stainless steel and consists of a shaft that terminates in a single or double flat, sharpened blade that is straight, curved, or angled. 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

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ESAM14065470STOMA®14065.4714065.472025-04-30
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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

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