Sensation

GUDID 00190730002938

Sensation Roth 022 UR 4/5 HkRx -7° Tor. 0° Ang. (10PK)

ORTHO TECHNOLOGY, INC.

Orthodontic bracket, ceramic

• Primary Device ID: 00190730002938
• NIH Device Record Key: 9321e20c-ad8b-445d-8f48-a7e27461d90e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sensation
• Version Model Number: 180-12-1910
• 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	00190730002938 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112707

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 [Sensation]

• 00190730003171: Sensation MBT 022 L1/2 Rx -6° Tor. 0° Ang.(10PK)
• 00190730003164: Sensation MBT 022 LL4/5 Hk Rx -12° Tor. 0° Ang.(10PK)
• 00190730003157: Sensation MBT 022 LL3 Hk Rx 0° Tor. +3° Ang.(10PK)
• 00190730003140: Sensation MBT 022 LR4/5 Hk Rx -12° Tor. 0° Ang.(10PK)
• 00190730003133: Sensation MBT 022 LR3 Hk Rx 0° Tor. +3° Ang.(10PK)
• 00190730003126: Sensation MBT 022 UL4/5 Hk Rx -7° Tor. 0° Ang.(10PK)
• 00190730003119: Sensation MBT 022 UL3 Hk Rx +0° Tor. +8° Ang.(10PK)
• 00190730003102: Sensation MBT 022 UL2 Rx +10° Tor. +8° Ang.(10PK)
• 00190730003096: Sensation MBT 022 UL1 RX +17° Tor. +4° Ang.(10PK)
• 00190730003089: Sensation MBT 022 R 5x5 Hks 345 SPK
• 00190730003072: Sensation MBT 022 UR 4/5 HkRx -7° Tor. 0° Ang.(10PK)
• 00190730003065: Sensation MBT 022 UR3 Hk Rx +0° Tor. +8° Ang.(10PK)
• 00190730003058: Sensation MBT 022 UR2 Rx +10° Tor. +8° Ang.(10PK)
• 00190730003041: Sensation MBT 022 UR1 Rx +17° Tor. +4° Ang.(10PK)
• 00190730003034: Sensation Roth 022 L1/2 Rx 0° Tor. 0° Ang. (10PK)
• 00190730003027: Sensation Roth 022 LL4/5 Hk Rx -17° Tor. 0° Ang.(10PK)
• 00190730003010: Sensation Roth 022 LL3 Hk Rx -11° Tor. +7° Ang. (10PK)
• 00190730003003: Sensation Roth 022 LR4/5 Hk Rx -17° Tor. 0° Ang. (10PK)
• 00190730002990: Sensation Roth 022 LR3 Hk Rx -11° Tor. +7° Ang. (10PK)
• 00190730002983: Sensation Roth 022 UL4/5 Hk Rx -7° Tor. 0° Ang. (10PK)
• 00190730002976: Sensation Roth 022 UL3 Hk Rx -2° Tor. +8° Ang. (10PK)
• 00190730002969: Sensation Roth 022 UL2 Rx +8° Tor. +9° Ang(10PK)
• 00190730002952: Sensation Roth 022 UL1 RX +11° Tor. +5° Ang. (10PK)
• 00190730002945: Sensation Roth 022 R 5x5 Hks 345 SPK
• 00190730002938: Sensation Roth 022 UR 4/5 HkRx -7° Tor. 0° Ang. (10PK)
• 00190730002921: Sensation Roth 022 UR3 Hk Rx -2° Tor. +8° Ang. (10PK)
• 00190730002914: Sensation Roth 022 UR2 Rx +8° Tor. +9° Ang. (10PK)
• 00190730002907: Sensation Roth 022 UR1 Rx +11° Tor. +5° Ang.(10PK)