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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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GC CROWNTEK™ Starter Package, 5 crowns each of 35 sizes, Upper Right Central Incisors: 1+.3, 1+.4, 1 +.5, 1+.6, 1+.7, Upper Right Cuspids 3+.5, 3+.6, Upper Left Central Incisors: +1.3, _1.4, +1.5, +1.6, +1.7, Upper Left Cuspids: +3.5, +3.6, Upper Right Laterals: 2+.2, 2+.3, 2+.4, 2+.5, Lower Right Cuspids: 3-.3, 3-.4, Upper Left Laterals: +2.2, +2.3, +2.4, +2.5, Lower Left Cuspids: -3.3, -3.4, Lower Centrals & Laterals: -1-2-.6, -1-2-.7, Bicuspids: 2, 3, 4, 5, 6, 7. 8
Gc America Inc.
412063
Not in Commercial Distribution

  • D6584120631 ()
  • D6584120630 ()
412063

  • Preformed dental crown, temporary
1. Description: AH Plus Bioceramic Sealer is a root canal sealer conforming to ISO 6876, in a pre-loaded syringe that does not require any pre-mixing and is set by absorbing moisture from the root canal environment. The sealer can be used either alone or in combination with gutta-percha obturating cones, injected gutta-percha material or core-carriers master cones. 2. Principle of operation: AH Plus Bioceramic Sealer is a tricalcium-silicate based endodontic sealer as a premixed and preloaded syringe type. AH Plus Bioceramic Sealer between the root canal and the root canal filling materials(ex. Gutta percha) by using sealing properties. 3. Storage conditions: 1) The product must be stored at room temperature (15 - 25°C) avoiding high temperature and humidity. 2) After use do not recap the used 24-gauge tip, remove and dispose tip as per national laws and recommendations of local authorities. 3) Clean the outside of the syringe and remove any excess sealer and twist the storage cap provided with the product tightly onto the syringe head. 4) Place the syringe into the foil pouch and ensure to seal the pouch. 4. Shelf life: 2 years from date of manufacture. 2) After use do not recap the used 24-gauge tip, remove and dispose tip as per national laws and recommendations of local authorities. 3) Clean the outside of the syringe and remove any excess sealer and twist the storage cap provided with the product tightly onto the syringe head. 4) Place the syringe into the foil pouch and ensure to seal the pouch. 4. Shelf life: 2 years from date of manufacture.
MARUCHI
Starter Kit
In Commercial Distribution

  • D075BKTAHBS0000001 ()


  • Hygroscopic dental cement
1. Description: AH Plus Bioceramic Sealer is a root canal sealer conforming to ISO 6876, in a pre-loaded syringe that does not require any pre-mixing and is set by absorbing moisture from the root canal environment. The sealer can be used either alone or in combination with gutta-percha obturating cones, injected gutta-percha material or core-carriers master cones. 2. Principle of operation: AH Plus Bioceramic Sealer is a tricalcium-silicate based endodontic sealer as a premixed and preloaded syringe type. AH Plus Bioceramic Sealer between the root canal and the root canal filling materials(ex. Gutta percha) by using sealing properties. 3. Storage conditions: 1) The product must be stored at room temperature (15 - 25°C) avoiding high temperature and humidity. 2) After use do not recap the used 24-gauge tip, remove and dispose tip as per national laws and recommendations of local authorities. 3) Clean the outside of the syringe and remove any excess sealer and twist the storage cap provided with the product tightly onto the syringe head. 4) Place the syringe into the foil pouch and ensure to seal the pouch. 4. Shelf life: 2 years from date of manufacture.
MARUCHI
Syringe Refill
In Commercial Distribution

  • D075B00AHBS10003G2 ()
00093

  • Hygroscopic dental cement
OPERATORY LIGHT - HALOGEN, WALL MOUNT, W/TALL RIGID ARM & REMOTE TRANSFORMER, 110 VOLT, FOREST GREY
Ls Enterprises, Inc.
9093W-T-G
In Commercial Distribution

  • D0699093WTG0 ()


  • Operating room light
OPERATORY LIGHT - HALOGEN, WALL MOUNT, W/TALL RIGID ARM & REMOTE TRANSFORMER, 110 VOLT, DESIGNER FRIENDLY
Ls Enterprises, Inc.
9093W-T-C
In Commercial Distribution

  • D0699093WTC0 ()


  • Operating room light
OPERATORY LIGHT - HALOGEN, WALL MOUNT, W/TALL RIGID ARM & REMOTE TRANSFORMER, 110 VOLT
Ls Enterprises, Inc.
9093W-T
In Commercial Distribution

  • D0699093WT0 ()


  • Operating room light
OPERATORY LIGHT - HALOGEN, WALL MOUNT, W/REMOTE TRANSFORMER, 110 VOLT, FOREST GREY
Ls Enterprises, Inc.
9093W-G
In Commercial Distribution

  • D0699093WG0 ()


  • Operating room light
OPERATORY LIGHT - HALOGEN, WALL MOUNT, W/REMOTE TRANSFORMER, 110 VOLT, DESIGNER FRIENDLY
Ls Enterprises, Inc.
9093W-C
In Commercial Distribution

  • D0699093WC0 ()


  • Operating room light
OPERATORY LIGHT, WALL MOUNT, BANFIELD WITH 24" SHORT RIGID ARM DESIGNER FRIENDLY: ARCTIC SILVER
Ls Enterprises, Inc.
9093W-BF-SA-C
In Commercial Distribution

  • D0699093WBFSAC0 ()


  • Operating room light
OPERATORY LIGHT, WALL MOUNT, BANFIELD WITH 60" RIGID ARM DESIGNER FRIENDLY: ARCTIC SILVER
Ls Enterprises, Inc.
9093W-BF-C
In Commercial Distribution

  • D0699093WBFC0 ()


  • Operating room light
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