tomas®

GUDID J011302004150

tomas® anchorage system: tomas®-screw driver allen set screw

DENTAURUM GmbH & Co.KG

Surgical screwdriver, reusable

• Primary Device ID: J011302004150
• NIH Device Record Key: df711157-dfa7-47bb-87d2-8d843b035c38
• Commercial Distribution Discontinuation: 2021-06-02
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: tomas®
• Version Model Number: 302-004-15
• Company DUNS: 315427286
• Company Name: DENTAURUM GmbH & Co.KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J011302004150 [Primary]

FDA Product Code

• NDP: ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[J011302004150]

Moist Heat or Steam Sterilization

[J011302004150]

Moist Heat or Steam Sterilization

[J011302004150]

Moist Heat or Steam Sterilization

[J011302004150]

Moist Heat or Steam Sterilization

[J011302004150]

Moist Heat or Steam Sterilization

[J011302004150]

Moist Heat or Steam Sterilization

[J011302004150]

Moist Heat or Steam Sterilization

[J011302004150]

Moist Heat or Steam Sterilization

[J011302004150]

Moist Heat or Steam Sterilization

[J011302004150]

Moist Heat or Steam Sterilization

[J011302004150]

Moist Heat or Steam Sterilization

[J011302004150]

Moist Heat or Steam Sterilization

[J011302004150]

Moist Heat or Steam Sterilization

[J011302004150]

Moist Heat or Steam Sterilization

[J011302004150]

Moist Heat or Steam Sterilization

[J011302004150]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-06-02
• Device Publish Date: 2016-09-15

On-Brand Devices [tomas®]

• J011302001200: tomas® anchorage system: tomas®-auxiliary kit (set of accessories)/ For further information pl
• J011302602000: tomas® RPE eyelet / coupling element for RPE screws between tomas®-pin with hyrax® or hyrax®
• J011302050000: tomas® anchorage system: tomas®-abutment kit (Accessories for abutments) / For further informa
• J011302027000: tomas® anchorage system: tomas®-abutment EP (Coupling element)
• J011302026000: tomas® anchorage system: tomas®-abutment plain (Coupling element)
• J011302025510: tomas® anchorage system: tomas®-abutments median
• J011302025300: tomas® anchorage system: tomas®-abutment double tube 1.5
• J011302025220: tomas® anchorage system: tomas®-abutment tube square 22 (Couping element with tube)
• J011302025210: tomas® anchorage system: tomas®-U-wire
• J011302025150: tomas® anchorage system: tomas®-abutment tube 1.5 (Couping element with tube)
• J011302025120: tomas® anchorage system: tomas®-abutment wire 12 (Coupling element with wire)
• J011302025110: tomas® anchorage system: tomas®-abutment tube 1.1 (Couping element with tube)
• J011302025060: tomas® anchorage system: tomas®-abutment wire 6 (Coupling element with wire)
• J011302025000: tomas® anchorage system: tomas®-abutment universal (Coupling element)
• J011302103400: tomas® anchorage system: tomas®-drill SD 1.1 SP, short pilot drill
• J011302103000: tomas® anchorage system: tomas®-drill SD 1.1, short pilot drill
• J011302003110: tomas® anchorage system: tomas®-drill 1.1, long pilot drill
• J011302003100: tomas® anchorage system: tomas®-drill 1.0, pilot drill
• J011302003080: tomas® anchorage system: tomas®-drill 1.1 T8, pilot drill (pilot bur)
• J011302003000: tomas® anchorage system: tomas®-round drill 1.0
• J011302080000: tomas® anchorage system: tomas® guide driver / For further information please visit our online
• J011302010100: tomas® anchorage system: tomas®-pin N 10 (non-sterile)/ Length 10 mm/sterilizable/ Core ø 1.2
• J011302006300: tomas® anchorage system: tomas®-pin N 06 (non-sterile) / Length 6 mm / sterilizable/ Core ø 1
• J011302006110: tomas® anchorage system: tomas®-pin 06 (sterile) / Core ø 1.2 mm / Length 6 mm / For further
• J011302006100: tomas® anchorage system: tomas®-pin N 06 (non-sterile)/ Length 6 mm/ sterilizable/Core ø 1.2
• J011302004150: tomas® anchorage system: tomas®-screw driver allen set screw
• J011302018000: tomas®-power chain (plastic chain)
• J011302004120: tomas® anchorage system: tomas®-screw driver tip
• J011302004180: tomas® anchorage system: tomas®-screwdriver tip
• J011302028010: tomas® anchorage system: tomas®-transfer cap
• J011302024000: tomas® anchorage system: tomas®-T-wire
• J011302009000: tomas® anchorage system: tomas®-uprighting spring
• J011302004800: tomas® anchorage system: tomas®-handpiece (Manually turned unit)
• J011302001000: tomas® anchorage system: tomas®-punch (gingiva remover)
• J011302004400: tomas® anchorage system: tomas®-torque ratchet / For further information please visit our onli
• J011302210300: tomas® anchorage system: tomas®-pin EP N 10 (unsterile)/ Length 10 mm/ sterilizable/Core ø 1.
• J011302210100: tomas® anchorage system: tomas®-pin EP N 10 (unsterile)/ Length 10 mm/ sterilizable/ Core ø 1
• J011302210000: tomas® anchorage system: tomas®-pin EP 10 (sterile) Core ø 1.2 mm / Length 10 mm / For furt
• J011302208300: tomas® anchorage system: tomas®-pin EP N 08 (unsterile)/ Length 8 mm/ sterilizable/ Core ø 1.
• J011302208100: tomas® anchorage system: tomas®-pin EP N 08 (unsterile)/ Length 8 mm/ sterilizable/ Core ø 1.
• J011302208000: tomas® anchorage system: tomas®-pin EP 08 (sterile) Core ø 1.2 mm / Length 8 mm / For furthe
• J011302206300: tomas® anchorage system: tomas®-pin EP N 06 (unsterile)/ Length 6 mm/ sterilizable/ Core ø 1.
• J011302206100: tomas® anchorage system: tomas®-pin EP N 06 (unsterile)/ Length 6 mm/ sterilizable / Core ø 1
• J011302206000: tomas® anchorage system: tomas®-pin EP 06 (sterile) Core ø 1.2 mm / Length 6 mm / For furthe
• J011302110300: tomas® anchorage system: tomas®-pin SD N 10 (non-sterile) Length 10 mm/ sterilizable/ Core ø1
• J011302110100: tomas® anchorage system: tomas®-pin SD N 10 (non-sterile) Length 10 mm/ sterilizable/ Core ø1
• J011302110000: tomas® anchorage system: tomas®-pin SD 10 (sterile) / Core ø 1.2 mm / Length 10 mm/ For fur
• J011302108300: tomas® anchorage system: tomas®-pin SD N 08 (non-sterile) Length 8 mm/ sterilizable/ Core ø 1
• J011302108100: tomas® anchorage system: tomas®-pin SD N 08 (non-sterile)/ Length 8 mm/ sterilizable/ Core ø1
• J011302108000: tomas® anchorage system: tomas®-pin SD 08 (sterile)/ Core ø 1.2 mm / Length 8 mm / For furth