510(k) K920645
- Device
- Orthodontic Elastics Bands
- Applicant
- MASEL INDUSTRIES, INC.
- 510(k) number
- K920645
- Product code
- EJF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-07-28
- Date received
- 1992-02-12
- Regulation
- 872.5410
- Classification name
- Bracket, Metal, Orthodontic
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT BRIGHT
- Address
- 2701 Bartram Rd. Bristol PA US 19007 19007
FDA Registration Numbers#
- 3013552516
- 3034278341
- 1054415
- 3009646973
- 3033011342
- 3002966425
- 3004753334
- 3006237499
- 1420089
- 3030680214
- 3015259864
- 3009402818
- 3013504876
- 3004201548
- 3015548849
- 3010517827
- 3011539071
- 3007279910
- 3014253211
- 3004730002
- 3034693059
- 1222301
- 3043648115
- 3034725654
- 3014054179
- 3009540749
- 2081322
- 3007010296
- 8044058
- 3006155566
- 3015276158
- 3007065358
- 3027520354
- 3010065389
- 3013519244
- 3008323540
- 3011554142
- 3021023132
- 3006291983
- 1937100
- 3005014825
- 3032911850
- 3027460334
- 3004704962
- 3013528406
- 3009171220
- 3015272949
- 3022296393
- 3009257060
- 3014737068
- 1815540
- 3007616048
- 1000118628
- 3017903664
- 1718476
- 2024980
- 3004776555
- 3013641573
- 3009646999
- 3006946041
- 3015337428
- 3009268271
- 3006621310
- 3027343382
- 3032027578
- 3009491780
- 3003236702
- 3012101632
- 3008081327
- 3010117482
- 3013508670
- 3030265369
- 3009514056
- 1293141
- 3007962015
- 3013689189
- 1526352
- 3012715571
- 3010669020
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EJF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K994357 | BITEM LOCK, MODELS SW006, SW012 | Thermoelastic Technologies, Inc. | 2000-03-14 |
| K932825 | MICROARCH GOLD BRACKET | Gac Intl., Inc. | 1994-05-09 |
| K933501 | ALASTIK | Unitek Corp. | 1994-04-28 |
| K923372 | MEMORY WIRE | Althan, Inc. | 1994-04-22 |
| K933080 | ORTHOTECH DURA-GOLD BARCKETS | Orthotech | 1994-03-23 |
| K935139 | FASCINATION CERAMIC BRACKET | Dentauraum, Inc. | 1994-02-04 |
| K936244 | REGENCY BRACKET | Mid-American Dental Specialties, Inc. | 1994-02-02 |
| K934881 | REFLECTIONS | Cdb Corp. | 1994-02-01 |
| K935122 | DENTAURUM METAL BRACKETS | Dentauraum, Inc. | 1994-01-31 |
| K926427 | LARIAT PALATE EXPANDER | Easy Access Orthodontics, Inc. | 1994-01-26 |
| K925028 | FORESTADENT ORTHODONTIC BANDS | Forestadent | 1994-01-26 |
| K930881 | CHANNEL-EDGE BRACKET SYSTEM | Dualtek, Inc. | 1994-01-21 |
| K933758 | REGENCY PLUS BRACKET | Mid-American Dental Specialties, Inc. | 1994-01-18 |
| K922806 | ORMCO SPORTSGUARD | Ormco Corp. | 1993-10-20 |
| K932025 | ION-IMPLANTED NEO SENTALLOY | Gac Intl., Inc. | 1993-09-13 |