Last synced on 12 July 2024 at 11:04 pm

Indirect Bonding Tray

Page Type
Product Code
Definition
A tray or splint to enable bonding of multiple orthodontic brackets to tooth surfaces.
Physical State
Solid thermoplastic
Technical Method
Brackets are aligned on a stone model. The tray or splint is formed over the model and is placed intraorally in the patient. After bonding of the brackets, the tray or splint is lifted and discarded.
Target Area
Intraoral
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
872.5410
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.5410 Orthodontic appliance and accessories

§ 872.5410 Orthodontic appliance and accessories.

(a) Identification. An orthodontic appliance and accessories is a device intended for use in orthodontic treatment. The device is affixed to a tooth so that pressure can be exerted on the teeth. This device includes the preformed orthodontic band, orthodontic band material, orthodontic elastic band, orthodontic metal bracket, orthodontic wire clamp, preformed orthodontic space maintainer, orthodontic expansion screw retainer, orthodontic spring, orthodontic tube, and orthodontic wire.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38799, July 25, 2001]

Indirect Bonding Tray

Page Type
Product Code
Definition
A tray or splint to enable bonding of multiple orthodontic brackets to tooth surfaces.
Physical State
Solid thermoplastic
Technical Method
Brackets are aligned on a stone model. The tray or splint is formed over the model and is placed intraorally in the patient. After bonding of the brackets, the tray or splint is lifted and discarded.
Target Area
Intraoral
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
872.5410
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.5410 Orthodontic appliance and accessories

§ 872.5410 Orthodontic appliance and accessories.

(a) Identification. An orthodontic appliance and accessories is a device intended for use in orthodontic treatment. The device is affixed to a tooth so that pressure can be exerted on the teeth. This device includes the preformed orthodontic band, orthodontic band material, orthodontic elastic band, orthodontic metal bracket, orthodontic wire clamp, preformed orthodontic space maintainer, orthodontic expansion screw retainer, orthodontic spring, orthodontic tube, and orthodontic wire.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38799, July 25, 2001]