PURE

GUDID 00190730003706

PURE® Roth 022 LR3 Hk Rx -11º Tor. +7º Ang.(10PK)

ORTHO TECHNOLOGY, INC.

Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic

• Primary Device ID: 00190730003706
• NIH Device Record Key: d5f3bdec-08b8-4e4f-bf25-911c7cef90e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PURE
• Version Model Number: S22151
• 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	00190730003706 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073045

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: 2018-09-21
• Device Publish Date: 2016-09-24

On-Brand Devices [PURE]

• 00190730004291: PURE® McLaughlin 022 LL5 Rx -17º Tor. +2º Ang.(10PK)
• 00190730004284: PURE® McLaughlin 022 LR5 Rx -17º Tor. +2º Ang.(10PK)
• 00190730004277: PURE® McLaughlin 022 LL5 Hk Rx -17º Tor. +2º Ang.(10PK)
• 00190730004260: PURE® McLaughlin 022 LR5 Hk Rx -17º Tor. +2º Ang.(10PK)
• 00190730004253: PURE® 022 M 5x5 Hks 345 SPK Upper Only
• 00190730004246: PURE® McLaughlin 022 LL4 Rx -12º Tor. +2º Ang.(10PK)
• 00190730004239: PURE® McLaughlin 022 LR4 Rx -12º Tor. +2º Ang.(10PK)
• 00190730004222: PURE® McLaughlin 022 LL4 Hk Rx -12º Tor. +2º Ang.(10PK)
• 00190730004215: PURE® McLaughlin 022 LR4 Hk Rx -12º Tor. +2º Ang.(10PK)
• 00190730004208: PURE® 022 M 5x5 Hks 3 SPK Upper Only
• 00190730004192: PURE® McLaughlin 022 LL3 Rx 0º Tor. +3º Ang.(10PK)
• 00190730004185: PURE® McLaughlin 022 LR3 Rx 0º Tor. +3º Ang.(10PK)
• 00190730004178: PURE® McLaughlin 022 LL3 Hk Rx 0º Tor. +3º Ang.(10PK)
• 00190730004161: PURE® McLaughlin 022 LR3 Hk Rx 0º Tor. +3º Ang.(10PK)
• 00190730004154: PURE® 022 M 5x5 SPK Upper Only
• 00190730004147: PURE® McLaughlin 022 L1/2 Rx -6º Tor. 0º Ang.(10PK)
• 00190730004130: PURE® 022 M 5x5 Hks 345 SPK
• 00190730004123: PURE® McLaughlin 022 U 4/5 Rx -7º Tor. 0º Ang.(10PK)
• 00190730004116: PURE® McLaughlin 022 UL 4/5 Hk Rx -7º Tor. 0º Ang.(10PK)
• 00190730004109: PURE® McLaughlin 022 UR 4/5 Hk Rx -7º Tor. 0º Ang.(10PK)
• 00190730004093: PURE® 022 M 5x5 Hks 3 SPK
• 00190730004086: PURE® McLaughlin 022 UL3 Rx 0º Tor. +8º Ang.(10PK)
• 00190730004079: PURE® McLaughlin 022 UR3 Rx 0º Tor. +8º Ang.(10PK)
• 00190730004062: PURE® McLaughlin 022 UL3 Hk Rx 0º Tor. +8º Ang.(10PK)
• 00190730004055: PURE® McLaughlin 022 UR3 Hk Rx 0º Tor. +8º Ang.(10PK)
• 00190730004048: PURE® 022 M 5x5 SPK
• 00190730004031: PURE® McLaughlin 022 UL2 Rx +10º Tor. +8º Ang.(10PK)
• 00190730004024: PURE® McLaughlin 022 UR2 Rx +10º Tor. +8º Ang.(10PK)
• 00190730004017: PURE® 022 M 3x3 SPK
• 00190730004000: PURE® McLaughlin 022 UL1 Rx +17º Tor. +4º Ang.(10PK)
• 00190730003997: PURE® McLaughlin 022 UR1 Rx +17º Tor. +4º Ang.(10PK)
• 00190730003980: PURE® 022 M 3x3 Hks 3 SPK
• 00190730003973: PURE® 022 S 5x5 Hks 3 SPK
• 00190730003966: PURE® Edgewise 022 L R/L 1/2 Rx 0º Tor. 0º Ang.(10PK)
• 00190730003959: PURE® Edgewise 022 U/L R/L 4/5 Rx 0º Tor. 0º Ang.(10PK)
• 00190730003942: PURE® Edgewise 022 UL/LR 3 Hk Rx 0º Tor. 0º Ang.(10PK)
• 00190730003935: PURE® Edgewise 022 UR/LL 3 Hk Rx 0º Tor. 0º Ang.(10PK)
• 00190730003928: PURE® Edgewise 022 U/L R/L 3 Rx 0º Tor. 0º Ang.(10PK)
• 00190730003911: PURE® Edgewise 022 U R/L 2 Rx 0º Tor. 0º Ang.(10PK)
• 00190730003904: PURE® Edgewise 022 U R/L 1 Rx 0º Tor. 0º Ang.(10PK)
• 00190730003898: PURE® 022 R 5-5 Hks 3 SPK Lower Only
• 00190730003881: PURE® 022 R 4x4 SPK Upper Only
• 00190730003874: PURE® 022 R 5x5 Hks 345 SPK Upper Only
• 00190730003867: PURE® 022 R 5x5 Hks 3 SPK Upper Only
• 00190730003850: PURE® 022 S 5x5 SPK
• 00190730003843: PURE® 022 R 5x5 Hks 345 SPK
• 00190730003836: PURE® 022 R 5x5 Hks 3 SPK
• 00190730003829: PURE® 022 R 5x5 SPK Upper Only
• 00190730003812: PURE® 022 R 5x5 SPK
• 00190730003805: PURE® 022 R 3x3 Hks 3 SPK