PURE®

GUDID 00190707107611

PURE® .018 R 5x5 Hks 345 SPK PURE

ORTHO ORGANIZERS, INC.

Orthodontic bracket, ceramic

• Primary Device ID: 00190707107611
• NIH Device Record Key: 29c5d56d-3b0f-4e60-a6dc-7dc20e98f1ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PURE®
• Version Model Number: S18340
• Company DUNS: 062165188
• Company Name: ORTHO ORGANIZERS, INC.
• 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: true
• 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	00190707107611 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-10-03
• Device Publish Date: 2025-09-25

On-Brand Devices [PURE®]

• 00190707108083: PURE® .022 M 5x5 Hks 345 SPK Upper Only PURE
• 00190707108038: PURE® .022 M 5x5 Hks 3 SPK Upper Only PURE
• 00190707107994: PURE® .022 M 5x5 Hks 345 SPK PURE
• 00190707107956: PURE® .022 M 5x5 Hks 3 SPK PURE
• 00190707107888: PURE® .022 M 3x3 Hks 3 SPK PURE
• 00190707107871: PURE® .022 S 5x5 Hks 3 SPK PURE
• 00190707107864: PURE® .022 R 5x5 Hks 345 SPK Upper Only PURE
• 00190707107857: PURE® .022 R 5x5 Hks 3 SPK Upper Only PURE
• 00190707107840: PURE® .022 R 5x5 Hks 345 SPK PURE
• 00190707107833: PURE® .022 R 5x5 Hks 3 SPK PURE
• 00190707107826: PURE® .022 R 3x3 Hks 3 SPK PURE
• 00190707107635: PURE® .018 S 5x5 Hks 3 SPK PURE
• 00190707107628: PURE® .018 R 5x5 Hks 345 SPK Upper Only PURE
• 00190707107611: PURE® .018 R 5x5 Hks 345 SPK PURE
• 00190707107604: PURE® .018 R 5x5 Hks 3 SPK PURE
• 00190707107598: PURE® .018 R 3x3 Hks 3 SPK PURE
• 10190707108127: PURE® McLaughlin .022 LL5 Rx -17° Tor. +2° Ang.(10PK)
• 10190707108110: PURE® McLaughlin .022 LR5 Rx -17° Tor. +2° Ang.(10PK)
• 10190707108103: PURE® McLaughlin .022 LL5 Hk Rx -17° Tor. +2° Ang.(10PK)
• 10190707108097: PURE® McLaughlin .022 LR5 Hk Rx -17° Tor. +2° Ang.(10PK)
• 10190707108073: PURE® McLaughlin .022 LL4 Rx -12° Tor. +2° Ang.(10PK)
• 10190707108066: PURE® McLaughlin .022 LR4 Rx -12° Tor. +2° Ang.(10PK)
• 10190707108059: PURE® McLaughlin .022 LL4 Hk Rx -12° Tor. +2° Ang.(10PK)
• 10190707108042: PURE® McLaughlin .022 LR4 Hk Rx -12° Tor. +2° Ang.(10PK)
• 10190707108028: PURE® McLaughlin .022 LL3 Hk Rx 0° Tor. +3° Ang.(10PK)
• 10190707108011: PURE® McLaughlin .022 LR3 Hk Rx 0° Tor. +3° Ang.(10PK)
• 10190707108004: PURE® McLaughlin .022 L1/2 Rx -6° Tor. 0° Ang.(10PK)
• 10190707107984: PURE® McLaughlin .022 U 4/5 Rx -7° Tor. 0° Ang.(10PK)
• 10190707107977: PURE® McLaughlin .022 UL 4/5 Hk Rx -7° Tor. 0° Ang.(10PK)
• 10190707107960: PURE® McLaughlin .022 UR 4/5 Hk Rx -7° Tor. 0° Ang.(10PK)
• 10190707107946: PURE® McLaughlin .022 UL3 Hk Rx 0° Tor. +8° Ang.(10PK)
• 10190707107939: PURE® McLaughlin .022 UR3 Hk Rx 0° Tor. +8° Ang.(10PK)
• 10190707107922: PURE® McLaughlin .022 UL2 Rx +10° Tor. +8° Ang.(10PK)
• 10190707107915: PURE® McLaughlin .022 UR2 Rx +10° Tor. +8° Ang.(10PK)
• 10190707107908: PURE® McLaughlin .022 UL1 Rx +17° Tor. +4° Ang.(10PK)
• 10190707107892: PURE® McLaughlin .022 UR1 Rx +17° Tor. +4° Ang.(10PK)
• 10190707107816: PURE® Roth .022 LL5 Hk Rx -21° Tor. 0° Ang.(10PK)
• 10190707107809: PURE® Roth .022 LR5 Hk Rx -21° Tor. 0° Ang.(10PK)
• 10190707107793: PURE® Roth .022 L5 Rx -21° Tor. 0° Ang.(10PK)
• 10190707107786: PURE® Roth .022 LL4 Hk Rx -17° Tor. 0° Ang.(10PK)
• 10190707107779: PURE® Roth .022 LR4 Hk Rx -17° Tor. 0° Ang.(10PK)
• 10190707107762: PURE® Roth .022 L4 Rx -17° Tor. 0° Ang.(10PK)
• 10190707107755: PURE® Roth .022 LL3 Hk Rx -11° Tor. +7° Ang.(10PK)
• 10190707107748: PURE® Roth .022 LR3 Hk Rx -11° Tor. +7° Ang.(10PK)
• 10190707107731: PURE® Roth .022 L1/2 Rx 0° Tor. 0° Ang.(10PK)
• 10190707107724: PURE® Roth .022 UL 4/5 Hk Rx -7° Tor. 0° Ang.(10PK)
• 10190707107717: PURE® Roth .022 UR 4/5 Hk Rx -7° Tor. 0° Ang.(10PK)
• 10190707107700: PURE® Roth .022 U 4/5 Rx -7° Tor. 0° Ang.(10PK)
• 10190707107694: PURE® Roth .022 UL3 Hk Rx 2° Tor. +8° Ang.(10PK)
• 10190707107687: PURE® Roth .022 UR3 Hk Rx +2° Tor. +8° Ang.(10PK)