FDA.reportPublic FDA data

tomas®

Primary DI
J011302001000
Brand
tomas®
Company
DENTAURUM GmbH & Co.KG
Model
302-001-00
Device description
tomas® anchorage system: tomas®-punch (gingiva remover)
Published
2016-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMEPUNCH, BIOPSY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMEPunch, Biopsy, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J011302001000PrimaryHIBCC0
J011302001001Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Gingiva-coring punch, single-useA dental instrument designed to remove with precision a circular area of gum tissue during dental surgery, typically to allow access to a site for drilling and dental implant placement without the use of a scalpel. It will typically be designed with a handle at the proximal end and a cylindrical hollow tube-like head with a sharp cutting edge at the distal end. It is made of disposable material (e.g., a hard plastic). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No special storage conditions required

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)523-3946info@dentaurum-us.com

Regulatory Flags#

DUNS number
315427286
Device count
4
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J011250301010ceraMotion®250-301-012026-09-25
J011250306010ceraMotion®250-306-012026-09-25
J011254012040ceraMotion®254-012-042026-09-25
J011254014040ceraMotion®254-014-042026-09-25
J011302150000tomas®302-150-002026-09-04
J011302250000tomas®302-250-002026-09-04
J011520120000Noninium®520-120-002026-09-04
J011621040000Noninium®621-040-002026-09-04
J011621404000Noninium®621-404-002026-09-04
J011621407000Noninium®621-407-002026-09-04
J011130131000N.A.130-131-002020-08-28
J011130137000N.A.130-137-002020-08-28
J011130138000N.A.130-138-002020-08-28
J011130324000N.A.130-324-002020-08-28
J011130634000N.A.130-634-002020-08-28
J011262411100Carmen®262-411-102016-09-15
J011262412100Carmen®262-412-102016-09-15
J011262415100Carmen®262-415-102016-09-15
J011262421100Carmen®262-421-102016-09-15
J011262422100Carmen®262-422-102016-09-15

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Primary DI, Brand, Company table
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05060411987579Oral Rotating Biopsy Punch 120 mmDTR MEDICAL LIMITEDEME2026-06-12
05060411987586Oral Biopsy Punch Long 180 mmDTR MEDICAL LIMITEDEME2026-06-12
05060212051066Oral Biopsy Forceps 90mmDTR MEDICAL LIMITEDEME2026-06-11
05060212051073Oral Biopsy Forceps Long 120mmDTR MEDICAL LIMITEDEME2026-06-11
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