Bite-Bumper BB-00-01

GUDID 07333117000070

Gestenco International AB

Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use Orthodontic bracket, plastic, single-use

• Primary Device ID: 07333117000070
• NIH Device Record Key: b3cacd2b-b4b3-4007-b1dd-188c7d751030
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bite-Bumper
• Version Model Number: BB-00-01
• Catalog Number: BB-00-01
• Company DUNS: 354936098
• Company Name: Gestenco International AB
• 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: 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	07333117000070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053055

FDA Product Code

• DYW: Bracket, Plastic, 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: 2016-10-11

Devices Manufactured by Gestenco International AB

• 07333117000032 - SmartBond: 2020-10-23
• 07333117000049 - SmartBond: 2020-10-23
• 07333117000056 - SmartBond LC: 2020-10-23
• 07333117000063 - SmartBond LC: 2020-10-23
• 07333117000148 - Cheek retractor: 2020-10-23
• 07333117000162 - Lip Retractor: 2020-10-23
• 07333117000179 - Lip Retractor: 2020-10-23
• 07333117000087 - Freddy: 2020-10-22