Identity
- Trade Name
- Bite-Bumper FDA UDI
- Generic Name
- Orthodontic bracket, plastic, single-use FDA UDI
- Device Name
- Bite Bumpers™ work to open deep bite cases by allowing the anteriors to ride up and out of occlusion. The Bite Bumpers™ eliminate bond failures of brackets and are especially valuable with ceramic or self-ligating brackets. The unique fixed "placement-jig" guarantees the correct height on the lingual of the tooth an makes sure the two Bite Bumpers™ are 100% parallel. The Bite Bumpers™ are made of a composite polymer that is more comfortable, aesthetic and will increase biocompatibility in nickel sensitive patients. Bite-Bumpers™ are bonded in the same manner as plastic or composite brackets with a slotted mechanical bonding base. Bite Bumper is a registered trademark by Gestenco International AB, Sweden FDA UDI
- Model / Reference
- BB-00-01 FDA UDI
- Description
- Bite Bumpers™ work to open deep bite cases by allowing the anteriors to ride up and out of occlusion. The Bite Bumpers™ eliminate bond failures of brackets and are especially valuable with ceramic or self-ligating brackets. The unique fixed "placement-jig" guarantees the correct height on the lingual of the tooth an makes sure the two Bite Bumpers™ are 100% parallel. The Bite Bumpers™ are made of a composite polymer that is more comfortable, aesthetic and will increase biocompatibility in nickel sensitive patients. Bite-Bumpers™ are bonded in the same manner as plastic or composite brackets with a slotted mechanical bonding base. Bite Bumper is a registered trademark by Gestenco International AB, Sweden FDA UDI
Identifiers
- Catalog Number
- BB-00-01 FDA UDI
- Primary DI / UDI-DI
- 10190886000748 FDA UDI
- 510(k) Number
- K053055 FDA UDI
- FDA Product Code
- DYW FDA UDI
- GMDN Term
- Orthodontic bracket, plastic, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5470 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthodontic bracket, plastic, single-use
Bite-Bumper by G&H Wire Company, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic bracket, plastic, single-use.
- Silkon Plus — American Orthodontics · Class II
- Carriere® Motion Pro™ — Ortho Organizers, Inc. · Class II
- Silkon Plus — American Orthodontics · Class II
- Carriere — Ortho Organizers, Inc. · Class I
- OrthoFlex — ORTHO TECHNOLOGY, INC. · Class II
- OrthoFlex — ORTHO TECHNOLOGY, INC. · Class II
- Avalon — ORTHO TECHNOLOGY, INC. · Class II
- Silkon Plus — American Orthodontics · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- G&H Wire Company, Inc.
Sources (1)
- FDA UDI b6c1b0eb-7f01-402e-9c31-6d6ce5d5a3ff 36 fields · synced Jun 8, 2026