Reflections

GUDID 00190730005755

Reflections 022 U4/5 Hk Roth Rx -7º Tor. 0º Ang.(10PK)

ORTHO TECHNOLOGY, INC.

Orthodontic bracket, ceramic

• Primary Device ID: 00190730005755
• NIH Device Record Key: def91ad8-94c7-4d0f-ba89-37e478e10e38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reflections
• Version Model Number: REF-131
• Company DUNS: 781772017
• Company Name: ORTHO TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190730005755 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922499

FDA Product Code

• NJM: Bracket, ceramic, orthodontic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Reflections]

• 00190730006561: *Reflections® 018/022 RV 5x5 SPK Hks 345 Bi-Dimensional
• 00190730006554: Reflections® 022 M 3x3 Hks 3 SPK
• 00190730006547: Reflections® 022 M 5x5 Hks345 SPK
• 00190730006530: Reflections® 022 M 5x5 Hks 3 SPK
• 00190730006523: Reflections® 018 M 3x3 Hks 3 SPK
• 00190730006516: Reflections® 018 M 5x5 Hks345 SPK
• 00190730006509: Reflections® 018 M 5x5 Hks 3 SPK
• 00190730006493: Reflections® 022 RV 5x5 Hks 345 SPK
• 00190730006486: Reflections® 022 RV 5x5 Hks 3 SPK
• 00190730006479: Reflections® 022 R 5x5 Hks345 SPK Upper Only
• 00190730006462: Reflections® 022 R 5x5 Hks 3 SPK Upper Only
• 00190730006455: Reflections® 022 R 5x5 SPK Upper Only
• 00190730006448: Reflections® 022 R 3x3 Hks 3 SPK
• 00190730006431: Reflections® 022 R 5x5 Hks345 SPK Upper Only
• 00190730006424: Reflections® 022 R 5x5 Hks 3 SPK Upper Only
• 00190730006417: *Reflections® 022 SE 5x5 SPK
• 00190730006400: Reflections® 022 R 5x5 Hks 345 SPK
• 00190730006394: Reflections® 022 R 5x5 Hks 3 SPK
• 00190730006387: **Reflections® 022 R 5x5 SPK
• 00190730006370: Reflections® 018 R 5x5 Hks345 SPK Upper Only
• 00190730006363: Reflections® 018 R 5x5 Hks 3 SPK Upper Only
• 00190730006356: Reflections® 018 R 5x5 SPK Upper Only
• 00190730006349: Reflections® 018 R 3x3 Hks 3 SPK
• 00190730006332: Reflections® 018 R 5x5 Hks345 SPK Upper Only
• 00190730006325: Reflections® 018 R 5x5 Hks 3 SPK Upper Only
• 00190730006318: *Reflections® R 018/022 5x5 SPK Hks 345 Bi-Dimensional
• 00190730006301: Reflections® 018 R 5x5 Hks 345 SPK
• 00190730006295: Reflections® 018 R 5x5 Hks 3 SPK
• 00190730006288: *Reflections® 018 BP 5x5 Hks345 SPK
• 00190730006271: Ref Cer McLaughlin 022 LL5 Rx -17º Tor. +2º Ang.(10PK)
• 00190730006264: Ref Cer McLaughlin 022 LR5 Rx -17º Tor. +2º Ang.(10PK)
• 00190730006257: Ref Cer McLaughlin 022 LL5 Hk Rx -17º Tor. +2º Ang.(10PK)
• 00190730006240: Ref Cer McLaughlin 022 LR5 Hk Rx -17º Tor. +2º Ang.(10PK)
• 00190730006233: Ref Cer McLaughlin 022 LL4 Rx -12º Tor. +2º Ang.(10PK)
• 00190730006226: Ref Cer McLaughlin 022 LR4 Rx -12º Tor. +2º Ang.(10PK)
• 00190730006219: Ref Cer McLaughlin 022 LL4 Hk Rx -12º Tor. +2º Ang.(10PK)
• 00190730006202: Ref Cer McLaughlin 022 LR4 Hk Rx -12º Tor. +2º Ang.(10PK)
• 00190730006196: Ref Cer McLaughlin 022 LL3HK Rx 0º Tor. +3º Ang.(10PK)
• 00190730006189: Ref Cer McLaughlin 022 LR3HK Rx 0º Tor. +3º Ang.(10PK)
• 00190730006172: Ref Cer McLaughlin 022 L1/2 Rx -6º Tor. 0º Ang.(10PK)
• 00190730006165: Ref Cer McLaughlin 022 U4/5Hk Rx -7º Tor. 0º Ang.(10PK)
• 00190730006158: Ref Cer McLaughlin 022 U4/5 Rx -7º Tor. 0º Ang.(10PK)
• 00190730006141: Ref Cer McLaughlin 022 UL3HK Rx 0º Tor. +8º Ang.(10PK)
• 00190730006134: Ref Cer McLaughlin 022 UR3HK Rx 0º Tor. +8º Ang.(10PK)
• 00190730006127: Ref Cer McLaughlin 022 UL2 Rx +10º Tor. +8º Ang.(10PK)
• 00190730006110: Ref Cer McLaughlin 022 UR2 Rx +10º Tor. +8º Ang.(10PK)
• 00190730006103: Ref Cer McLaughlin 022 UL1 Rx +17º Tor. +4º Ang.(10PK)
• 00190730006097: Ref Cer McLaughlin 022 UR1 Rx +17º Tor. +4º Ang.(10PK)
• 00190730006080: Reflections V-Slot 022 L5 Hk Roth Rx -22º Tor. 0º Ang.(10PK)
• 00190730006073: Reflections V-Slot 022 L5 Roth Rx -22º Tor. 0º Ang.(10PK)