Color Additives Approved for Use in Medical Devices
Part 73, Subpart D: Color additives exempt from batch certification |
21 CFR Section |
Straight Color |
Year(2)Approved |
Uses and Restrictions |
§73.1015 |
Chromium-cobalt-aluminum oxide |
1974 |
Linear polyethylene surgical sutures NTE(7) 2% general surgery. |
§73.1025 |
Ferric ammonium citrate |
1973 |
With pyrogallol for coloring plain or chromic catgut sutures; NTE(7) 3% general and ophthalmic surgery. |
§73.1375 |
Pyrogallol |
1973 |
With ferric ammonium citrate for coloring plain or chromic catgut sutures; NTE(7) 3% general and ophthalmic surgery. |
§73.1410 |
Logwood extract |
1977 |
For coloring nylon 66, nylon 6, or silk non-absorbable sutures; NTE(7) 1% general and ophthalmic surgery. |
§73.3100 |
1,4-Bis[(2-hydroxy-ethyl)amino]-9,10-anthracenedione bis(2-propenoic)ester copolymers(3)
|
1996 |
Contact lenses |
§73.3105 |
1,4-Bis [(2-methylphenyl)amino] -9,10-anthracenedione(3)
|
1984 |
Contact lenses. |
§73.3106 |
1,4-Bis[4- (2-methacryloxyethyl) phenylamino] anthraquinone copolymers(3)
|
1990 |
Contact lenses. |
§73.3106 |
1,4-Bis[4- (2-methacryloxyethyl) phenylamino] anthraquinone copolymers(3)
|
1993 |
Added copolymer, renamed. |
§73.3106 |
1,4-Bis[4- (2-methacryloxyethyl) phenylamino] anthraquinone copolymers(3)
|
1995 |
Additional copolymer. |
§73.3107 |
Carbazole violet(3)
|
1988 |
Contact lenses. |
§73.3110 |
Chlorophyllin-copper complex, oil soluble(3)
|
1984 |
Bone cement only NTE(7) 0.003%. |
§73.3110a |
Chromium-cobalt-aluminum oxide(3)
|
1988 |
Contact lenses. |
§73.3111 |
Chromium oxide greens(3)
|
1986 |
Contact lenses. |
§73.3112 |
C.I. Vat Orange 1(3)
|
1985 |
Contact lenses. |
§73.3115 |
2-[[2,5-Diethoxy- 4-[(4-methylphenyl)thiol] phenyl]azo] -1,3,5-benzenetriol(3)
|
1983 |
Formed in situ in soft contact lenses to mark L and R NTE(7) 1.1x10-7 g/lens. |
§73.3117 |
16,23-Dihydrodinaphtho [2,3-a:2',3'-i] naphth [2',3':6,7] indolo [2,3-c] carbazole- 5,10,15,17,22,24-hexone(3)
|
1983 |
Contact lenses. |
§73.3118 |
N,N'-(9,10-Dihydro- 9,10-dioxo- 1,5-anthracenediyl) bisbenzamide(3)
|
1983 |
Contact lenses. |
§73.3119 |
7,16-Dichloro- 6,15-dihydro- 5,9,14,18-anthrazinetetrone(3)
|
1983 |
Contact lenses. |
§73.3120 |
16,17-Dimethoxydinaphtho (1,2,3-cd:3',2',1'-lm) perylene-5,10-dione(3)
|
1983 |
Contact lenses. |
§73.3121 |
Poly(hydroxyethyl methacrylate) -dye copolymers(3): one or more of (1) Reactive Black 5 |
1984 |
Contact lenses. |
(2) Reactive Blue 21 |
1984 |
(3) Reactive Orange 78 |
1984 |
(4) Reactive Yellow 15 |
1984 |
(5) Reactive Blue No. 19 |
1985 |
(6) Reactive Blue No. 4 |
1985 |
(7) C.I. Reactive Red 11 |
1985 |
(8) C.I. Reactive Yellow 86 |
1985 |
(9) C.I. Reactive Blue 163 |
1985 |
(10) C.I. Reactive Red 180 |
1993 |
§73.3122 |
4-[(2,4-dimethylphenyl)azo]- 2,4-dihydro- 5-methyl-2-phenyl- 3H-pyrazol-3-one(3)
|
1986 |
Contact lenses. |
§73.3123 |
6-Ethoxy-2- (6-ethoxy-3-oxobenzo[b] thien-2(3H)- ylidene) benzo[b]thiophen- 3(2H)-one(3)
|
1986 |
Contact lenses. |
§73.3124 |
Phthalocyanine green(3)
|
1986 |
Contact lenses. |
§73.3125 |
Iron oxides(3)
|
1986 |
Contact lenses. |
§73.3126 |
Titanium dioxide(3)
|
1986 |
Contact lenses. |
§73.3127 |
Vinyl alcohol/methyl methacrylate-dye reaction products(3); one or more of: (1) C.I. Reactive Red 180 |
1993 |
Contact lenses. |
§73.3127 |
Vinyl alcohol/methyl methacrylate-dye reaction products(3); one or more of: (2) C.I. Reactive Black 5 |
1993 |
Contact lenses. |
§73.3127 |
Vinyl alcohol/methyl methacrylate-dye reaction products(3); one or more of: (3) C.I. Reactive Orange 78 |
1993 |
Contact lenses. |
§73.3127 |
Vinyl alcohol/methyl methacrylate-dye reaction products(3); one or more of: (4) C.I. Reactive Yellow 15 |
1993 |
Contact lenses. |
§73.3127 |
Vinyl alcohol/methyl methacrylate-dye reaction products(3); one or more of: (5) C.I. Reactive Blue No. 19 |
1993 |
Contact lenses. |
§73.3127 |
Vinyl alcohol/methyl methacrylate-dye reaction products(3); one or more of: (6) C.I. Reactive Blue 21 |
1993 |
Contact lenses. |
§73.3128 |
Mica-based pearlescent pigments(3)
|
2002 |
Contact lenses |
§73.3129 |
Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate (Reactive Blue 69)(3)
|
2011 |
Contact lenses |
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