ORTHOSOURCE

GUDID D9115578630

Ortho Lite Cure Sealant 8 gm Bottle

ORTHOSOURCE

Orthodontic bracket adhesive

• Primary Device ID: D9115578630
• NIH Device Record Key: 8067731c-dd95-4ac7-87b1-e939d374e44a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHOSOURCE
• Version Model Number: 557-863
• Company DUNS: 151289394
• Company Name: ORTHOSOURCE
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D9115578630 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K913854

FDA Product Code

• DYH: Adhesive, Bracket And Tooth Conditioner, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-25
• Device Publish Date: 2019-12-17

On-Brand Devices [ORTHOSOURCE]

• D911TST5080: TAPERED SELF THREADING Internal Hex Thread Implant 5.0 x 8
• D911TST50160: TAPERED SELF THREADING Internal Hex Thread Implant 5.0 x 16
• D911TST50130: TAPERED SELF THREADING Internal Hex Thread Implant 5.0 x 13
• D911TST501150: TAPERED SELF THREADING Internal Hex Thread Implant 5.0 x 11.5
• D911TST50100: TAPERED SELF THREADING Internal Hex Thread Implant 5.0 x 10
• D911TST4280: TAPERED SELF THREADING Internal Hex Thread Implant 4.2 x 8
• D911TST42160: TAPERED SELF THREADING Internal Hex Thread Implant 4.2 x 16
• D911TST42130: TAPERED SELF THREADING Internal Hex Thread Implant 4.2 x 13
• D911TST421150: TAPERED SELF THREADING Interal Hex Thread Implant 4.2 x 11.5
• D911TST42100: TAPERED SELF THREADING Internal Hex Thread Implant 4.2 x 10
• D911TST37580: TAPERED SELF THREADING Internal Hex Thread Implant 3.75 x 8
• D911TST375160: TAPERED SELF THREADING Internal Hex Thread Implant 3.75 x 16
• D911TST375130: TAPERED SELF THREADING Interal Hex Thread Implant 3.75 x 13
• D911TST3751150: TAPERED SELF THREADING Internal Hex Thread Implant 3.75 x 11.5
• D911TST375100: TAPERED SELF THRADING Internal Hex Thread Implant 3.75 x 10
• D911TST3380: TAPERED SELF THREADING Internal Hex Thread Implant 3.3 x 8
• D911TST33160: TAPERED SELF THREADING Internal Hex Thread Implant 3.3 x 16
• D911TST33130: TAPERED SELF THREADING Internal Hex Thread Impalnt 3.3 x 13
• D911TST331150: TAPERED SELF THREADING Internal Hex Thread Implant 3.3 x 11.5
• D911TST33100: TAPERED SELF THREADING Internal Hex Implant 3.3 x 10
• D9113LT5080: 3 LOBE Tapered Thread Implant 5.0 x 8
• D9113LT50160: 3 LOBE Tapered Thread Implant 5.0 x 16
• D9113LT50130: 3 LOBE Tapered Thread Implant 5.0 x 13
• D9113LT50100: 3 LOBE Tapered Thread Implant 5.0 x 10
• D9113LT4380: 3 LOBE Tapered Thread Implant 4.3 x 8
• D9113LT43160: 3 LOBE Tapered Thread Implant 4.3 x 16
• D9113LT43130: 3 LOBE Tapered Thread Implant 4.3 x 13
• D9113LT43100: 3 LOBE Tapered Thread Implant 4.3 x 10
• D9113LT3580: 3 LOBE Tapered Thread Implant 3.5 x 8
• D9113LT35160: 3 LOBE Tapered Thread Implant 3.5 x 16
• D9113LT35130: 3 LOBE Tapered Thread Implant 3.5 X 13
• D9113LT35100: 3 LOBE Tapered Thread Implant 3.5 x 10
• D911PBC6080: BONE CONDENSING PLUS Tapered Thread Implant 6.0 x 8
• D911PBC6060: BONE CONDENSING PLUS Tapered Thread Implant 6.0 x 6
• D911PBC601150: BONE CONDENSING PLUS Tapered Thread Implant 6.0 x 11.5
• D911PBC60100: BONE CONDENSING PLUS Tapered Thread Implant 6.0 x 10
• D911PBC5080: BONE CONDENSING PLUS Tapered Thread Implant 5.0 x 8
• D911PBC5060: BONE CONDENSING PLUS Tapered Thread Implant 5.0 x 6
• D911PBC50160: BONE CONDENSING PLUS Tapered Thread Implant 5.0 x 16
• D911PBC50130: BONE CONDENSING PLUS Tapered Thread Implant 5.0 x 13
• D911PBC501150: BONE CONDENSING PLUS Tapered Thread Implant 5.0 x 11.5
• D911PBC50100: BONE CONDENSING PLUS Tapered Thread Implant 5.0 x 10
• D911PBC4380: BONE CONDENSING PLUS Tapered Thread Implant 4.3 x 8
• D911PBC4360: BONE CONDENSING PLUS Tapered Thread Implant 4.3 x 6
• D911PBC43160: BONE CONDENSING PLUS Tapered Thread Implant 4.3 x 16
• D911PBC43130: BONE CONDENSING PLUS Tapered Thread Implant 4.3 x 13
• D911PBC431150: BONE CONDENSING PLUS Tapered Thread Implant 4.3 x 11.5
• D911PBC43100: BONE CONDENSING PLUS Tapered Thread Implant 4.3 x 10
• D911PBC3580: BONE CONDENSING PLUS Tapered Thread Implant 3.5 x 8
• D911PBC35160: BONE CONDENSING PLUS Tapered Thread Implant 3.5 x 16